FORMA FROZEN BLOOD THAWING DEVICES MANUFACTURED BY THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC

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Request for Information Form	Contact Information
Company Name	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
Address	MILLCREEK RD.
City, State, Zip	MARIETTA, OH 45750
Country	US
FDA Owner/Operator Phone	--
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	KZL
FDA Classification Name	DEVICE, WARMING. BLOOD AND PLASMA
FDA Device Classification Code	Standards
FDA Regulation Number	864.9205
FDA Common Generic Name	VARIOUS MODELS OF THAWING DEVICES
FDA Proprietary Device Name	FORMA FROZEN BLOOD THAWING DEVICES
FDA Owner / Operator Number	2182773
FDA Owner / Operator Name	THERMO FISHER SCIENTIFIC INC.
FDA Establishment Registration Number	1523845
FDA Registered Establishment Name	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	04-22-94
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ARIZANT HEALTHCARE INC. 10393 WEST 70TH ST. EDEN PRAIRIE, MN 55344 US 952-947-1200 / 952-947-1200	241 BLOOD/FLUID WARMING PRODUCTS	BLOOD/FLUID WARMER
2	ARK BIO-MEDICAL CANADA CORP. DARTREY ESTATE DE L'ILE #671 RUSTICO RD. ROUTE 7 MILTONVALE PARK, WINSLOE, CIE 124 CA 902-892-5244 / 954-527-8553	ARKBIO/WESLABS	ARKBIO PLASMA DEFROSTER OR WESLABS PLASMA DEFROSTER
3	CYTOTHERM 110 SEWELL AVE. TRENTON, NJ 08610 US 609-396-1456 / 609-396-1456	CYTO THERM CT-4T, CT-DR, CT-D4, CT-D2, CT-4S	WET AND DRY MODEL OF TABLETOP PLASMA THAWERS
4	ELLTEC CO., LTD. SHIRAKAWA NO. 6 BLDG. 2-18-5, NISHIKI, NAKA-KU NAGOYA, 460-0003 JA 81-52-2017308 / 81-52-2017308	ANIMEC	ANIMEC
5	SARSTEDT AG & CO. ROMMELSDORFER STR. NUMBRECHT, N. RHINE-WESTPHALIA, 51588 GM 49-229-330550 / 49-229-3305500	SAHARA	BLOOD THAWING/WARMING DEVICE
6	THE SURGICAL COMPANY INTERNATIONAL BV TERMINALWEG 19A,3821 AJ AMERSFOORT, NL 31-33-4508366 / 31-33-4508366	FLUIDO BLOOD AND FLUID WARMER SYSTEM	BLOOD AND FLUID WARMER SYSTEM