Fenwal Y-Type Blood Comp. Recipient Set with Std. 4C2161

GUDID 14052682004190

Y-Type Blood Component Recipient Set with Standard Blood Filter and Luer Adapter. Sterile Fluid Path

Fresenius Kabi AG

Blood transfusion set
Primary Device ID14052682004190
NIH Device Record Keydf54ff23-302b-4972-8cee-062148d061b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameFenwal Y-Type Blood Comp. Recipient Set with Std.
Version Model Number4C2161
Catalog Number4C2161
Company DUNS315654579
Company NameFresenius Kabi AG
Device Count1
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

Customer Support Contacts

Phone1-800-933-6925
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104052682004193 [Primary]
GS114052682004190 [Package]
Contains: 04052682004193
Package: Box [48 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BRZSet, Blood Transfusion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-26

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