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EXHALOMETER FILTER
 Request for Information Form |
 Contact Information
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| Company Name | CALDYNE, INC. |
| Address | 2425 MARYLAND ROAD |
| City, State, Zip | WILLOW GROVE, PA 19090 |
| Country | US |
| FDA Owner/Operator Phone | 215-830-3076 |
| FDA Medical Specialty Code | AN - Anesthesiology |
| FDA Product Code | CAH |
| FDA Classification Name | FILTER, BACTERIAL, BREATHING-CIRCUIT |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 868.5260 |
| FDA Common Generic Name | BFE/VFE EXHALOMETER FILTER |
| FDA Proprietary Device Name | EXHALOMETER FILTER |
| FDA Owner / Operator Number | 9073206 |
| FDA Owner / Operator Name | CALDYNE, INC. |
| FDA Establishment Registration Number | 3005351302 |
| FDA Registered Establishment Name | CALDYNE, INC. |
| FDA Operation Code(s) |
MS - Specification Developer |
| FDA Listing Date | 10-07-05 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of CALDYNE, INC.
Our records indicate that the following medical device companies may manufacture a similar device.| Company Name / Address / Phone | Proprietary Device Name | Common Generic Device Name | |
| 1 | ACCENT PLASTICS 1925 ELISE CIRCLE CORONA, CA 92879 US 951-273-7777 / 951-273-7777 |
MICROGARD MICROBIOLOGY FILTER | MICROGARD |
| 2 | AG INDUSTRIES 3637 SCARLETT OAK BLVD. ST. LOUIS, MO 63122 US 636-349-4466 / 636-349-4466 |
BREATHING FILTER BACTERIAL,VIRAL | BREATHING FILTER |
| 3 | AIR SAFETY LTD NFC HOUSE, MELLISHAW LANE MORECAMBE, LANCS, LA3 3EN UK 44-15-24847600 / 440-152-4847600 |
BACTERIAL/VIRAL FILTER | HEPA OR NON-HEPA FILTERS |
| 4 | ALLIANCE TECH MEDICAL, INC. 5305 MISSION CIRCLE GRANBURY, TX 76049 US 817-326-3183 / 661-588-5102 |
ALL FLOW PULMONARY FUNCTION FILTER | PULMONARY FUNCTION FILTER |
| 5 | A-M SYSTEMS, INC. 131 BUSINESS PARK LOOP P.O. BOX 850 CARLSBORG, WA 98324 US 360-683-8300 / 360-683-8300 |
BACTERIAL FILTER | |
| 6 | AMERASIA CORPORATION TAI HE INDUSTRIAL DEVELOPMENT QINGYUAN, GUANGDONG, CH 86-763-5882723 / 336-753-5000 |
FILTER, BACTERIAL, BREATHING-CIRCUIT ANESTHESIOLOGY | BACTERIAL FILTER |
| 7 | AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DR. POMONA, CA 91767 US 909-626-5888 / 909-626-5888 |
MULTIPLE | BACTERIAL & VIRAL FILTER |
| 8 | AMSINO MEDICAL (SHANGHAI) CO., LTD. SONGJIANG EXPORT PROCESSING ZONE PHASE V, LOT # 1-3 SHANGHAI, 201613 CH 86-21-62099901 / 909-626-5888 |
MULTIPLE | BACTERIAL AND VIRAL FILTER |
| 9 | BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. DRAPER, UT 84020 US 972-281-1200 / 770-587-8393 |
FILTER, BACTERIAL, BREATHING-CIRCUIT | FILTER, BACTERIAL, BREATHING-CIRCUIT |
| 10 | BIRD HEALTHCARE, PTY, LTD. 1/11 SABRE DRIVE PORT MELBOURNE VICTORIA, 3207 AS 61-396-452977 / 011-61-396452977 |
SUREGARD | RESPIRATORY & CPAP BACTERIAL/VIRAL FILTERS |
| 11 | BOMIMED INC. 96 TERRACON PL. WINNIPEG, MANITOBA, R2J 4G7 CA 204-633-2664x229 / 215-588-2999 |
AIR SAFETY LTD. PART NO. 2800 | AQUESURE PF FILTER-OL-000851 |
| 12 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1660 IOWA AVE., SUITE 100/200 RIVERSIDE, CA 92507 US 847-689-8410 / 847-578-6610 |
FILTER, BACTERIAL, BREATHING-CIRCUIT | FILTER, BACTERIAL, BREATHING-CIRCUIT |
| 13 | CHEEN HOUNG ENT. CO. LTD. 23 SAN DREEN ST., ALLEY 11, LANE 65 TAIPEI (SHULIN), 23805 TW / 886-2-26892468 |
BACTERIA FILTER | BACTERIA FILTER |
| 14 | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. 6135 GUNBARREL AVE. BOULDER, CO 80301 US 508-261-8587 / 303-305-2382 |
MULTIPLE | VARIOUS MODELS OF BACTERIAL FILTERS |
| 15 | CPM DE REYNOSA S.A. DE C.V. BRECHA 99 NTE. PARQUE INDUSTRIAL REYNOSA REYNOSA, TAMP., MX 405-872-3486 / 956-782-9970 |
FILTER, BACTERIAL, BREATHING-CIRCUIT | FILTER, BACTERIAL, BREATHING-CIRCUIT |
| 16 | CREATIVE BIOMEDICS, INC. 924-A CALLE NEGOCIO SAN CLEMENTE, CA 92673 US 949-366-2300 / 949-366-2300 |
DISPOSABLE PULMONARY FUNCTION FILTER | CLEAR ADVANTAGE FILTER |
| 17 | CUSTOM PLASTIC PRODUCTS 4529 HASTINGS COURT CHINO, CA 91710 US 909-717-6390 / 909-717-6390 |
LOTUS PULMONARY FUNCTION FILTER | SPIROMETER FILTER |
| 18 | DEROYAL SURGICAL - ROSE HILL 100 ROSE HILL INDUSTRIAL PARK ROSE HILL, VA 24281 US 865-938-7828 / 865-938-7828 1325 |
BACTERIAL FILTERS, CONVENIENCE KITS WITH ANESTHESIA BREATHING CIRCUITS & BACTERI | BACTERIAL FILTERS, ANESTHESIA BREATHING CIRCUIT KITS WITH BACTERIAL FILTERS, VAR |
| 19 | EMERGENCY FILTRATION PRODUCTS, INC. 175 CASSIA WAY, SUITE A115 HENDERSON, NV 89014 US 702-558-5164 / 702-558-5164 |
RESPAIDE,BACTERIAL/VIRAL FILTER | B/V FILTER, NANO MASK, NANO MASK 2, NANO MASK FILTER |
| 20 | EMERGENCY FILTRATION PRODUCTS, INC. GAVILANES #28, PARQUE INDUSTRIAL SAN RAMON NOGALES, SONORA, MX 702-558-5164 / 520-742-9820 |
BACTERIAL/VIRAL FILTER | B/V FILTER |
| 21 | ENTERNET MEDICAL, INC. 1676 VILLAGE GREEN CROFTON, MD 21114 US 888-887-6638 / 888-729-9674 |
FILTER, BACTERIAL, BREATHING-CIRCUIT | VARIOUS TYPES OF BACTERIA FILTERS |
| 22 | FIM MEDICAL 30, RUE CAMILLE LYON, 69003 FR 33-4-72348989 / 847-374-8854 |
ERGOFILTER SP-1 | SPIROMETER FILTER |
| 23 | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE EAST TAMAKI, NZ 649-574-0100 / 649-574-0123x8309 |
NONE | BREATHING CIRCUIT BACTERIAL FILTER |
| 24 | GALEMED CORP. 87, LI-GONG 2ND RD., WU-JIA, I-LAN, 268 TW 886-3-9908618 / 886-3-9908618 |
FILTER, BACTERIAL, BREATHING-CIRCUIT#ANESTHESIOLOGY | BACTERIAL FILTER |
| 25 | GALEMED XIAMEN CO., LTD. AMOY EXPORT ZONE, 39. SEC 3 HAIJING RD FUJIAN PROVINCE, CH 886-3-9908618 / 886-3-9908618 |
FILTER, BACTERIAL, BREATHING | BACTERIA FILTER |
| 26 | GAMBRO ENGSTROM AB KARLSBODAVAGEN 18 BROMMA, SW |
MULTIPLE | BREATHING CIRCUIT BACTERIAL FILTER |
| 27 | GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 HELSINKI, FIN-00510 FI 847-277-5002 / 414-721-3945 |
MULTIPLE | BREATHING CIRCUIT BACTERIAL FILTER |
| 28 | GISH BIOMEDICAL, INC. 22942 ARROYO VISTA RANCHO SANTA MARGARITA, CA 92688 US 949-635-6200 / 949-635-6240 |
GAS LINE FILTER | STERILE SURGICAL GAS FILTER OR OXYGEN FILTER |
| 29 | GLOBAL MED, INC. 155 N. MURRAY ST. TRENTON, ON, K8V5R5 CA 613-394-9844 / 613-394-9844 |
ANESTHESIA/RESPIRATORY BACTERIAL/VIRAL FILTER | TRANSPARENT ANESTHESIA FILTER |
| 30 | INMED MFG.SDN.BHD,RUSCH., TELEFLEX MEDICAL P.O. BOX 28, KAMUNTING INDUSTRIAL ESTATE, KAMUNTING PERAK, 34600 MY 919-544-8000 / 919-433-4829 |
MULTIPLE BREATHING CIRCUIT BACTERIAL FILTERS | VARIOUS TYPES OF BREATHING CIRCUIT BACTERIAL FILTERS |
| 31 | INTERSURGICAL LIMITED-GUERNSEY CIRCUIT HOUSE, PITRONNERIE RD ST. PETER PORT, GUERNSEY, UK / 315-451-2900 |
MULTIPLE | VARIOUS TYPES OF BACTERIAL/VIRAL BREATHING FILTERS |
| 32 | INTERSURGICAL UAB ARNIONIU 60/28-1 PABRADE, LT-4710 LH / 315-451-2900 |
MULTIPLE | VARIOUS TYPES OF BACTERIAL/VIRAL BREATHING FILTERS |
| 33 | INTERSURGICAL, INC. 417 ELECTRONICS PKWY. LIVERPOOL, NY 13088 US 315-451-2900 / 315-451-2900 |
MULTIPLE | VARIOUS TYPES OF BACTERIAL/VIRAL BREATHING FILTERS |
| 34 | JOSTRA BENTLEY, INC. RD. 402 N. KM 1.4 INDUSTRIAL PARK ANASCO, PR 00610 US 49-747-8921-0 / 302-454-9959 |
BIOLOGIC GAS LINE FILTER | BIOLOGIC GAS LINE FILTER |
| 35 | KAZ (FAR EAST) LTD. SHENG GUANG INDUSTRIAL AREA HUANGPU,SHAJING,SHENZHEN, 518125 CH 518-828-0450 221 / 518-828-0450 221 |
HONEYWELL, ENVIRACARE | AIR CLEANER, FILTERS, VARIOUS TYPES |
| 36 | KAZ, INC. ONE VAPOR TRAIL HUDSON, NY 12534 US 518-828-0450 221 / 518-828-0450 221 |
VICKS, KAZ | AIR CLEANER, FILTERS |
| 37 | KING SYSTEMS CORP. 15011 HERRIMAN BLVD. NOBLESVILLE, IN 46060 US 317-776-6823 / 317-776-6823 346 |
FILTER, BACTERIAL, BREATHING CIRCUIT | |
| 38 | KUNG SHIN PLASTICS CO., LTD. 65-2, ERH CHIA ROAD YING KUO TOWN TAIPEI HSIEN, 23942 TW 886-2-26780366 / 886-3-5208829 |
SAYKIA, KUNG SHIN, ALLY | BREATHING CIRCUIT BACTERIAL FILTER |
| 39 | MALLINCKRODT DAR S.R.L. VIA G.BOVE, 2/4/6/8 MIRANDOLA (MODENA), 41037 IT 925-463-4371 / 925-463-4371 |
MULTIPLE | BACTERIAL FILTER, FILTER, BREATHING FILTER |
| 40 | MAQUET CRITICAL CARE AB 2 ROENTGENVAGEN SOLNA, S-17195 SW 114-687-307409 / 468-730-7125 |
MULTIPLE DEVICES | BREATHING CIRCUIT BACTERIAL FILTER |
| 41 | MEDEX DE MEXICO, S.A. DE C.V. CARRETERA MIGUEL ALEMAN,KM21.7 APODACA, NL, 66600 MX 114-420-8-458-3232 / 619-710-1104 |
FILT-R-ALL | BACTERIAL FILTER |
| 42 | MEDICOMP 12535 316TH AVE. P.O. BOX 322 PRINCETON, MN 55371 US 763-389-4473 / 763-389-4473 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 43 | MERCURY MEDICAL 11300 49TH ST. NORTH CLEARWATER, FL 33762 US 727-573-0088 / 813-784-8457 |
NONE | RESUSCITATION BAG EXHALATION FILTER |
| 44 | MUNKTELL FILTER AB SOLDATVAGEN 14 FALUN, SE-791 40 SW 011-462-3705880 / 011-46-23 705 880 |
FILTER, BACTERIAL, BREATHING-CIRCUIT (MULTIPLE BRANDS) | VARIOUS TYPES OF BREATHING FILTERS |
| 45 | NELLCOR PURITAN BENNETT MEXICO, S.A. DE C.V. 37 BLVD. INSURGENTES, LIBRIAMENTO A LA P., LA MESA TIJUANA, B.C., MX 925-463-4371 / 925-463-4000 |
MULTIPLE | VARIOUS MODELS OF BACTERIAL FILTERS |
| 46 | NSPIRE HEALTH, INC. 908 MAIN ST. LOUISVILLE, CO 80027 US 303-666-8100 / 303-666-5555 |
KOKO MOE | PULMONARY FUNCTION FILTERS |
| 47 | PALL BIOMEDICAL PRODUCTS CO. 2200 NORTHERN BLVD. EAST HILLS, NY 11548 US 516-484-5400 / 516-801-9064 |
MULTIPLE | VARIOUS |
| 48 | PALL BIOMEDICAL, INC. CARR. 194, KM. O.4 FAJARDO, PR 00738 US 516-484-5400 / 516-801-9064 |
PALL BREATHING CIRCUIT FILTER | BREATHING CIRCUIT FILTER |
| 49 | PALL NEWQUAY, LTD. ST. COLUMB MAJOR CORNWALL, TR9 6ST UK 516-484-5400 / 516-801-9064 |
ULTIPOR BREATHING CIRCUIT FILTER | BREATHING CIRCUIT FILTER AND FILTRATION SYS |
| 50 | POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. & PROCESS COMPLEX BUILDING XIANGYU F.T.Z. XIAMEN, 361012 CH 86-592-5624868 / 86-592-5624868 |
BACTERIAL FILTER | BACTERIAL FILTER |
| 51 | POROUS MEDIA CORP. 1350 HAMMOND RD. ST. PAUL, MN 55110 US 651-653-2000 / 651-653-2000 270 |
POROUS MEDICA DBF23 DISPOSABLE RESPIRATORY FILTER | BREATHING CIRCUIT FILTER |
| 52 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. CERRADA VIA DE LA PRODUCCION #85 PARQUE INDUST.MEXICALI III MEXICALI, B.C., 21600 MX 847-689-8410 / 847-578-6610 |
FILTER, BACTERIAL, BREATHING-CIRCUIT | FILTER, BACTERIAL, BREATHING-CIRCUIT |
| 53 | RENNELS MEDICAL CORP. 203 NORTHWOOD DR. MORGANTON, NC 28655 US 828-437-1085 / 828-437-1085 |
RENMED | VARIOUS MODELS OF BREATHING CIRCUIT FILTERS |
| 54 | SALTER LABS, DIVISION OF REGULATORY AFFAIRS 100 WEST SYCAMORE RD. ARVIN, CA 93203 US 661-854-3166 / 661-854-3166 |
SALTER LABS NEBULIZER AEROSOL FILTER | NEBULIZER AEROSOL FILTER |
| 55 | SDI DIAGNOSTICS, INC. 10 HAMPDEN DR. EASTON, MA 02375 US 508-238-7033 / 508-238-7033 |
PULMOGUARD DISPOSABLE BACTERIAL/VIRAL FILTER | SPIROMETER FILTER/PULMONARY FUNCTION TEST FILTER |
| 56 | SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. AVE. CALIDAD NO.4, PARQUE IND. INTERNACIONAL,OTAY UNIVERSIDAD TIJUANA, BC, 22425 MX 114-420-8-458-3232 / 619-710-1104 |
MULTIPLE | VARIOUS TYPES OF BREATHING CIRCUIT BACTERIAL FILTERS |
| 57 | SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. KEENE, NH 03431 US 114-420-8-458-3232 / 603-352-3812 2457 |
MULTIPLE | VARIOUS TYUPES OF BREATHING CIRCUIT BACTERIAL FILTERS |
| 58 | SMITHS MEDICAL ASD, INC. 160 WEYMOUTH ST. ROCKLAND, MA 02370 US 114-420-8-458-3232 / 603-352-3812 |
FILTER, BACTERIAL, BREATHING-CIRCUIT | BACTERIAL IN LINE BREATHING (AMBIENT AIR) FILTER |
| 59 | SMITHS MEDICAL INTERNATIONAL LTD. BOUNDIRY RD. HYTHE, KENT, CT 21 5BN UK 114-420-8-458-3232 / 44-130-3260551 |
THERMOVENT | BREATHING FILTER |
| 60 | SPIROMETRICS MEDICAL EQUIPMENT COMPANY, LLC 22 SHAKER ROAD GRAY, ME 04039 US 207-657-6700 / 207-657-6700 299 |
SPIRO-FILTER | PARTICULANT HYDROPHOBIC FILTER |
| 61 | TELEFLEX MEDICAL 920 WESTPORT PARKWAY FORT WORTH, TX 76177 US 919-544-8000 / 919-433-4829 |
MULTIPLE BREATHING CIRCUIT BACTERIAL FILTERS | VARIOUS TYPES OF BREATHING CIRCUIT BACTERIAL FILTERS |
| 62 | TELEFLEX MEDICAL 4024 STIRRUP CREEK DR. SUITE 720 DURHAM, NC 27703 US 919-544-8000 / 919-433-4829 |
MULTIPLE BREATHING CIRCUIT BACTERIAL FILTERS | VARIOUS TYPES OF BREATHING CIRCUIT BACTERIAL FILTERS |
| 63 | TELEFLEX MEDICAL AVE. INDUSTRIAS NO.5954 PARQUE INDUSTRIAL FINSA NUEVO LAREDO, TAMAULIPAS, 88275 MX 919-544-8000 / 919-433-4829 |
MULTIPLE BREATHING CIRCUIT BACTERIAL FILTERS | VARIOUS TYPES OF BREATHING CIRCUIT BACTERIAL FILTERS |
| 64 | TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. ELKTON, MD 21921 US 734-741-6238 / 800-283-7866 7420 |
GAS FILTER | FILTER |
| 65 | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 28 HOWE ST. ASHLAND, MA 01721 US 734-741-6238 / 800-283-7866 7420 |
MULTIPLE | GAS FILTER |
| 66 | UNOMEDICAL S.A. DE C.V. AV. INDUSTRIAL FALCON SECC. 4 LOTE 7, PARQUE IND. DEL NORTE REYNOSA, TAMS., MX 45-48-16 7000 / 956-683-8472 |
BACTERAIL FILTER | BACTERAIL FILTER |
| 67 | VENTLAB CORP. 155 BOYCE DRIVE MOCKSVILLE, NC 27028 US 336-753-5000 / 336-753-5000 |
FILTER, BACTERIAL, BREATHING CIRCUIT | |
| 68 | VENTLAB MEDICAL, ASIA-PACIFIC QIANWU INDUSTRY PARK DOUMEN DISTRICT, ZHUHAI GUANGDONG, 519170 CH 336-753-5000 / 336-753-5000 |
FILTER, BACTERIAL, BREATHING-CIRCUIT | BACTERIAL FILTER |
| 69 | VIASYS RESPIRATORY CARE INC. 22745 SAVI RANCH PKWY. YORBA LINDA, CA 92887 US 847-689-8410 / 714-919-3247 |
MICROGARD | MICROBIAL FILTER |
| 70 | VINCENT MEDICAL (DONG GUAN) MFG. CO., LTD. QIAO LONG DISTRICT, TANG XIA TOWN DONG GUAN CITY, GUANG DONG, 523730 CH 852-236-55688 / 852-236-55688 |
MULTIPLE | VARIOUS TYPES OF FILTERS |
| 71 | VITAL SIGNS COLORADO, INC. 11039 EAST LANSING CIR. ENGLEWOOD, CO 80112 US 973-790-1330 / 303-790-4835 |
MULTIPLE | FILTER |
| 72 | VITAL SIGNS, INC. 20 CAMPUS RD. TOTOWA, NJ 07512 US 973-790-1330 / 973-790-1330 356 |
BACTERIAL VIRAL FILTER | FILTER |
| 73 | WELLS JOHNSON CO. 8000 SOUTH KOLB RD. TUCSON, AZ 85706 US 520-298-6069 / 800-528-1597 |
BACTERIAL FILTERS | FILTERSATING, CIRCULATING FLUID |
| 74 | WESTMED, INC. BLVD ENCINO 100 BAJA, MX / 520-294-7987 x1205 |
CLEAR ANESTHESIA BREATHING CIRCUIT FILTER | B/U FILTER, HUMIDITY MOISTURE EXCHANGER FILTER (HMEF) |
| 75 | WESTMED, INC. 5580 S. NOGALES HIGHWAY TUCSON, AZ 85706 US 520-294-7987 1205 / 520-294-7987 1205 |
WESTMED CIRCULAIRE BACTERIAL/VIRAL FILTER | RESPIRATORY FILTER |
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