Fenwal Product Sample Pack 4R2335H

GUDID 14086000101421

For Sampling of Collected Blood and Blood Components. For Laboratory Testing Only. Sterile Fluid Path.

Fresenius Kabi AG

Blood transfer set
Primary Device ID14086000101421
NIH Device Record Key65c4d792-d601-4b17-970e-994c760c25ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameFenwal Product Sample Pack
Version Model Number4R2335H
Catalog Number4R2335H
Company DUNS315654579
Company NameFresenius Kabi AG
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Protect from freezing. Avoid excessive heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS104086000101424 [Unit of Use]
GS114086000101421 [Primary]
GS124086000101428 [Package]
Package: Carton [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-02

Devices Manufactured by Fresenius Kabi AG

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