N/A 2B8066

GUDID 50085412003257

Additive Cap

BAXTER INTERNATIONAL INC.

Intravenous administration bag/bottle
Primary Device ID50085412003257
NIH Device Record Key8020d8a1-7506-4e96-886c-715bd0cd82a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number2B8066
Catalog Number2B8066
Company DUNS005146311
Company NameBAXTER INTERNATIONAL INC.
Device Count300
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412003252 [Primary]
GS150085412003257 [Package]
Contains: 00085412003252
Package: CASE [900 Units]
In Commercial Distribution
GS170085412003251 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPECONTAINER, I.V.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-23
Device Publish Date2016-09-24

Devices Manufactured by BAXTER INTERNATIONAL INC.

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