FDA.reportPublic FDA data

Extension Set with EASY-LOCK Connector

Primary DI
07332414208059
Brand
Extension Set with EASY-LOCK Connector
Company
Vantive US Healthcare LLC
Model
5C4480C
Catalog number
5C4480C
Device description
This device is indicated for use in the treatment of patients with renal failure to provide extended length to the patient line of the Automated PD Disposable Sets.
Published
2026-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K925403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925403000BAXTER APD 12' EXTENSION LINEBaxter Healthcare Corp1994-02-22KDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57332414208054PackageGS130In Commercial Distribution
00085412087382PreviousGS10
07332414208059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5733241420805457332414208054
00085412087382000854120873820854120873820085412087382
07332414208059073324142080597332414208059

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage at room temperature

Contacts#

Phone, Email table
PhoneEmail
+1(800)284-4060US.customerservice@vantive.com

Regulatory Flags#

DUNS number
119533513
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
57332414206319Sharesource Connectivity Platform for Use with the Amia APD System5C94002026-09-22
07332414208028MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short5C44835C44832026-07-22
07332414254551MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWIST5C4482A5C4482A2026-07-06
07332414208417MANIFOLD SETL5C4446L5C44462026-06-22
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
07332414207946LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER5C41295C41292025-09-23
27332414207940LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER5C41295C41292025-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414208028MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra ShortVantive US Healthcare LLCKDJ2026-07-22
07332414254551MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWISTVantive US Healthcare LLCKDJ2026-07-06
07332414208417MANIFOLD SETVantive US Healthcare LLCKDJ2026-06-22
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
07332414207946LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETERVantive US Healthcare LLCKDJ2025-09-23
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