FDA.reportPublic FDA data

UltraSet CAPD Disposable Disconnect Y-Set

Primary DI
00085412030579
Brand
UltraSet CAPD Disposable Disconnect Y-Set
Company
BAXTER INTERNATIONAL INC.
Model
5C4366P
Catalog number
5C4366P
Device description
The UltraSet products are single use devices that are intended for the drainage and infusion of peritoneal dialysis solution.
Published
2015-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDJSET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDJSet, Administration, For Peritoneal Dialysis, DisposableGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961825000ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493Baxter Healthcare Corp1996-08-06KDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412030574PackageGS160In Commercial Distribution
00085412030579PrimaryGS10
90085412030572Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541203057450085412030574
00085412030579000854120305790854120305790085412030579
9008541203057290085412030572

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal dialysis system tubing setA sterile set intended for the administration of peritoneal dialysis. It will typically consist of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysis filter to trap and remove contaminating particles. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
005146311
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412002286INTERLINK/CONTINU-FLO2C65722C65722016-09-24
00085412002347INTERLINK2C66072C66072016-09-24
00085412002361INTERLINK2C66312C66312016-09-24
00085412003955INTERLINK2C66062C66062016-09-24
00085412004921INTERLINK2N33762N33762016-09-24
00085412013619INTERLINK1C83331C83332016-09-24
00085412014135INTERLINK1C84541C84542016-09-24
00085412017853INTERLINK/CONTINU-FLO3C00913C00912016-09-24
00085412051314CLEARLINK2N83772N83772016-09-24
00085412079677CLEARLINK/CONTINU-FLOACT8570ACT85702016-09-24
00085412079707CONTINU-FLO/DUO-VENTACT5543ACT55432016-09-24
00085412082592CLEARLINK/INTERLINK/DUO-VENTEMS3160EMS31602016-09-24
00085412000985Arthromatic/Uromatic2C40062C40062016-09-24
00085412001005Arthromatic/Uromatic2C40142C40142016-09-24
00085412014869Baxter1C86141C86142016-09-24
00085412000978Arthromatic/Uromatic2C40052C40052016-09-24
00085412001050Arthromatic/Uromatic2C40402C40402016-09-24
00085412001067Arthromatic/Uromatic2C40412C40412016-09-24
00085412004136Baxter2C76272C76272016-09-24
00085412027388VIAL-MATE2B80712B80712016-09-24

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10887488321462CARDINAL HEALTHCardinal Health 200, LLCKDJ2017-05-01
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