Fenwal Triple TRANSFER-PACK Container with Male Lu 4R2258

GUDID 04086000101431

Intended for Plasma Collection. Sterile Fluid Path.

Fresenius Kabi AG

Blood/tissue storage/culture container
Primary Device ID04086000101431
NIH Device Record Keycdfff96e-5950-4f9d-b63c-0ee3f0010d61
Commercial Distribution StatusIn Commercial Distribution
Brand NameFenwal Triple TRANSFER-PACK Container with Male Lu
Version Model Number4R2258
Catalog Number4R2258
Company DUNS315654579
Company NameFresenius Kabi AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from freezing. Avoid excessive heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS104086000101431 [Primary]
GS114086000101438 [Package]
Package: Carton [30 Units]
In Commercial Distribution

FDA Product Code

KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-02

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