UltraSet CAPD Disposable Disconnect Y-Set 5C4366P

GUDID 50085412030574

The UltraSet products are single use devices that are intended for the drainage and infusion of peritoneal dialysis solution.

BAXTER INTERNATIONAL INC.

Peritoneal dialysis system tubing set
Primary Device ID50085412030574
NIH Device Record Key035c8509-2ea0-4536-8fe5-93e1c82f3fe0
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraSet CAPD Disposable Disconnect Y-Set
Version Model Number5C4366P
Catalog Number5C4366P
Company DUNS005146311
Company NameBAXTER INTERNATIONAL INC.
Device Count10
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412030579 [Primary]
GS150085412030574 [Package]
Contains: 00085412030579
Package: CASE [60 Units]
In Commercial Distribution
GS190085412030572 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDJSET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

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 Date2015-10-07

On-Brand Devices [UltraSet CAPD Disposable Disconnect Y-Set]

50085412090080The UltraSet products are single use devices that are intended for the drainage and infusion of
50085412030574The UltraSet products are single use devices that are intended for the drainage and infusion of

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