APC-60i PRP Procedure Pack

GUDID 35020583514073

APC-60i PRP Procedure Pack

TERUMO BCT, INC.

Haematological concentrate system preparation kit, platelet concentration
Primary Device ID35020583514073
NIH Device Record Key8bed1e25-8394-4735-83d0-610c16ed6f53
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPC-60i PRP Procedure Pack
Version Model Number51407
Company DUNS801679200
Company NameTERUMO BCT, INC.
Device Count3
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(303)205-2510
EmailFDAUDIprogram@terumobct.com
Phone+1(303)205-2510
EmailFDAUDIprogram@terumobct.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105020583514072 [Unit of Use]
GS135020583514073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ORGPlatelet and plasma separator for bone graft handling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-09
Device Publish Date2016-09-15

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05020583705005 - COBE® Spectra 2022-09-01 Therapeutic Plasma Exchange Set

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