FDA.reportPublic FDA data

INTERGRATED APD SET

Primary DI
07332414208288
Brand
INTERGRATED APD SET
Company
Vantive US Healthcare LLC
Model
L5C4531
Catalog number
L5C4531
Device description
This integrated automated PD Set is compatible with Vantive Automated PD systems, Vantive PD Transfer Sets and Effluent Sample Bag. Integrated APD set with Cassette 3-Prong
Published
2026-10-21
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
FKXSystem, peritoneal, automatic delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKXSystem, Peritoneal, Automatic DeliveryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57332414208283PackageGS130In Commercial Distribution
00085412090078PreviousGS10
07332414208288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5733241420828357332414208283
00085412090078000854120900780854120900780085412090078
07332414208288073324142082887332414208288

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.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)553-6898Us.RENAL.Support.Co@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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414208301AUTOMATED PD SETR5C4479CR5C4479C2026-10-21
07332414208509LOW RECIRCULATION VOLUME APD SETN5C8305CN5C8305C2026-10-21
07332414208059Extension Set with EASY-LOCK Connector5C4480C5C4480C2026-10-07
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
07332414208301AUTOMATED PD SETVantive US Healthcare LLCFKX2026-10-21
07332414208509LOW RECIRCULATION VOLUME APD SETVantive US Healthcare LLCFKX2026-10-21
57332414206296Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemVantive Health GmbHFKX2026-09-22
57332414206319Sharesource Connectivity Platform for Use with the Amia APD SystemVantive US Healthcare LLCFKX2026-09-22
07332414202491Homechoice Claria APD CyclerVantive Health GmbHFKX2026-08-27
07332414208479HOMECHOICE APD SETVantive US Healthcare LLCFKX2025-10-16
08964004471001X-1 APD CyclerBYONYKS PRIVATE LIMITEDFKX2025-09-08
00085412030531NABaxter Healthcare SAFKX2025-08-28
50085412030536NABaxter Healthcare SAFKX2025-08-28
00840861102709LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
00840861102716LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
10840861102706LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
10840861102713LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
00840861102280VersiPDFresenius Usa, Inc.FKX2023-08-01
00840861102211VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102228VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102235VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102617VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102198VersiPDFresenius Usa, Inc.FKX2023-02-14
10840861102218VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
10840861102225VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
10840861102232VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102297VersiPDFresenius Usa, Inc.FKX2023-02-14
10840861102614VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00860006810238CloudCath Connect - Patient Monitoring SoftwareGastroklenz Inc.FKX2022-08-17
00860006810245CloudCath Drain Set - Fresenius ConfigurationGastroklenz Inc.FKX2022-08-12
00860006810207CloudCath Drain Set - Baxter ConfigurationGastroklenz Inc.FKX2022-08-12
00860006810269CloudCath Drain Set - Fresenius ConfigurationGastroklenz Inc.FKX2022-08-12
00860006810283CloudCath Sensor (Sensing Hardware)Gastroklenz Inc.FKX2022-08-05
00860006810214CloudCath Sensor (Sensing Hardware)Gastroklenz Inc.FKX2022-08-05