UltraSet CAPD Disposable Disconnect Y-Set L5C4366

GUDID 50085412090080

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 ID50085412090080
NIH Device Record Key8a970f32-74bb-4f9b-8818-194e999d3449
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraSet CAPD Disposable Disconnect Y-Set
Version Model NumberL5C4366
Catalog NumberL5C4366
Company DUNS005146311
Company NameBAXTER INTERNATIONAL INC.
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 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
GS100085412090085 [Primary]
GS150085412090080 [Package]
Contains: 00085412090085
Package: CASE [30 Units]
In Commercial Distribution

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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