FDA.reportPublic FDA data

LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER

Primary DI
07332414207946
Brand
LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER
Company
Vantive US Healthcare LLC
Model
5C4129
Catalog number
5C4129
Device description
This adapter is a double sealing female Luer lock adapter with a 2-piece, combination compression fit/barbed catheter connector. The adapter is used to connect the PD catheter to a solution transfer set with locking connector.
Published
2025-09-23
Public version status
New
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
K152675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152675000EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTERBaxter Healthcare2015-10-29KDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27332414207940PackageGS15In Commercial Distribution
57332414207941PackageGS139In Commercial Distribution
00085412007403PreviousGS10
07332414207946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2733241420794027332414207940
5733241420794157332414207941
00085412007403000854120074030854120074030085412007403
07332414207946073324142079467332414207946

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal dialysis catheter adaptor, single-useA connecting device, often in two pieces, intended to be used to join a peritoneal dialysis catheter to the dialysate line during treatment. It is typically made of plastic or metal and may be used when the devices to be connected are from different manufacturers and not compatible, enabling them to mate, and/or within a mechanical connection system. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature.

Contacts#

Phone, Email table
PhoneEmail
+1(800)553-6898osr.largo@vantive.com

Regulatory Flags#

DUNS number
119181963
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414208011FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTION5C44565C44562026-01-30
07332414208264MinicapEZPC4466EZPC44662026-01-30
57332414208016FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTION5C44565C44562026-01-30
57332414208269MinicapEZPC4466EZPC44662026-01-30
07332414208479HOMECHOICE APD SET5C4469C5C4469C2025-10-16
27332414207940LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER5C41295C41292025-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414208011FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTIONVantive US Healthcare LLCKDJ2026-01-30
07332414208264MinicapVantive US Healthcare LLCKDJ2026-01-30
57332414208016FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTIONVantive US Healthcare LLCKDJ2026-01-30
57332414208269MinicapVantive US Healthcare LLCKDJ2026-01-30
08964004471032Automated PD Set DS-1.BBYONYKS PRIVATE LIMITEDKDJ2025-11-13
08964004471049Automated PD Set DS-1.BBYONYKS PRIVATE LIMITEDKDJ2025-11-13
27332414207940LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETERVantive US Healthcare LLCKDJ2025-09-23
08964004471018Automated PD Set DS-1BYONYKS PRIVATE LIMITEDKDJ2025-09-08
08964004471025Automated PD Set DS-1BYONYKS PRIVATE LIMITEDKDJ2025-09-08
07332414207939CYCLER DRAINAGE BAGBAXTER HEALTHCARE CORPORATIONKDJ2025-03-20
57332414207934CYCLER DRAINAGE BAGBAXTER HEALTHCARE CORPORATIONKDJ2025-03-20
00085412841625MINICAP EXTENDED LIFE PD TRNSBAXTER HEALTHCARE CORPORATIONKDJ2024-08-05
20085412841629MINICAP EXTENDED LIFE PD TRNSBAXTER HEALTHCARE CORPORATIONKDJ2024-08-05
00085412722894Cycler Drainage BagBAXTER HEALTHCARE CORPORATIONKDJ2022-09-23
50085412722899Cycler Drainage BagBAXTER HEALTHCARE CORPORATIONKDJ2022-09-23
00085412656021MiniCapBAXTER HEALTHCARE CORPORATIONKDJ2019-07-22
50085412656026MiniCapBAXTER HEALTHCARE CORPORATIONKDJ2019-07-22
00840861102037Cycler Drain Bag SetFresenius Medical Care Holdings, Inc.KDJ2019-06-11
00085412007748MiniCapBAXTER HEALTHCARE CORPORATIONKDJ2017-12-21
50085412007743MiniCapBAXTER INTERNATIONAL INC.KDJ2017-12-21
10887488321462CARDINAL HEALTHCardinal Health 200, LLCKDJ2017-05-01
50887488321460CARDINAL HEALTHCardinal Health 200, LLCKDJ2017-05-01
00865349000308Firefly UV Disinfection DevicePURACATH MEDICAL, INCKDJ2016-11-21
00865349000315Firefly Transfer CatheterPURACATH MEDICAL, INCKDJ2016-11-21
00865349000339Firefly Luer CoverPURACATH MEDICAL, INCKDJ2016-11-21
00865349000353Firefly IPA BottlePURACATH MEDICAL, INCKDJ2016-11-21
00898021000051Alcavis 50Angelini Pharma Inc.KDJ2016-08-29
00898021000044Alcavis 50Angelini Pharma Inc.KDJ2016-08-29
20898021000055Alcavis 50ANGELINI PHARMA INC.KDJ2016-08-29
00827002089754TenckhoffCOOK INCORPORATEDKDJ2015-10-24