CHAMBER, ENVIRONMENTAL FOR THE STORAGE OF PLATELET CONCENTRATE MANUFACTURED BY HUMAN BIOSYSTEMS

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Request for Information Form	Contact Information
Company Name	HUMAN BIOSYSTEMS
Address	1127 HARKER AVE.
City, State, Zip	PALO ALTO, CA 94301
Country	US
FDA Owner/Operator Phone	650-323-0943
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	KSH
FDA Classification Name	CHAMBER, ENVIRONMENTAL FOR THE STORAGE OF PLATELET CONCENTRATE
FDA Device Classification Code	Standards
FDA Regulation Number	864.9575
FDA Common Generic Name	CONSENTRATE PLATELET PRESERVATION CONTAINER
FDA Proprietary Device Name	CHAMBER, ENVIRONMENTAL FOR THE STORAGE OF PLATELET CONCENTRATE
FDA Owner / Operator Number	9036892
FDA Owner / Operator Name	HUMAN BIOSYSTEMS
FDA Establishment Registration Number	2954283
FDA Registered Establishment Name	HUMAN BIOSYSTEMS
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	03-18-99
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	HELMER INC. 15322 HERRIMAN BLVD. NOBLESVILLE, IN 46060 US 317-773-9073 120 / 317-773-9073 120	HELMER PLATELET INCUBATOR	PLATELET INCUBATOR
2	HELMER INC. 15425 HERRIMAN BLVD. NOBLESVILLE, IN 46060 US 317-773-9073 120 / 317-773-9073 120
3	PRESVAC SRL CALLE 34 (EX. FRANCIA) 3917 SAN MARTIN BUENOS AIRES PROV., B1650IHM AR 541-147-543532 / 908-362-6807	PRESVAC SRL	PLATELET INCUBATOR AP48 LT, AP96LT
4	SARSTEDT AG & CO. ROMMELSDORFER STR. NUMBRECHT, N. RHINE-WESTPHALIA, 51588 GM 49-229-330550 / 49-229-3305500	MULTIPLE	PLATELET INCUBATOR
5	SO-LOW ENVIROMENTAL EQUIP CO., INC. 10310 SPARTAN DR. CINCINNATI, OH 45215 US 513-772-9410 / 513-772-9410		CHAMBER, CONSTANT TEMPERATURE (ENVIRONMENTAL)
6	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC MILLCREEK RD. MARIETTA, OH 45750 US / 740-373-4763 1859	THERMO ELECTRON OR THERMO FORMA	VARIOUS MODELS OF PLATELET INCUBATORS