FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTION 5C4456

GUDID 57332414208016

This device is a plastic disconnect cap for Automated Peritoneal Dialysis (APD) containing povidone-iodine.

Vantive US Healthcare LLC

Peritoneal dialysis system tubing set
Primary Device ID57332414208016
NIH Device Record Keye165f745-2346-48be-b9c6-6d15ee67f593
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTION
Version Model Number5C4456
Catalog Number5C4456
Company DUNS119181963
Company NameVantive US Healthcare LLC
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 Datetrue
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)284-4060
EmailUS.customerservice@vantive.com
Phone+1(800)284-4060
EmailUS.customerservice@vantive.com
Phone+1(800)284-4060
EmailUS.customerservice@vantive.com
Phone+1(800)284-4060
EmailUS.customerservice@vantive.com
Phone+1(800)284-4060
EmailUS.customerservice@vantive.com
Phone+1(800)284-4060
EmailUS.customerservice@vantive.com
Phone+1(800)284-4060
EmailUS.customerservice@vantive.com
Phone+1(800)284-4060
EmailUS.customerservice@vantive.com
Phone+1(800)284-4060
EmailUS.customerservice@vantive.com
Phone+1(800)284-4060
EmailUS.customerservice@vantive.com
Phone+1(800)284-4060
EmailUS.customerservice@vantive.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature . Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature . Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature . Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature . Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature . Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature . Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature . Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature . Avoid excessive heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412349145 [Previous]
GS107332414208011 [Primary]
GS157332414208016 [Package]
Contains: 07332414208011
Package: CA [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 Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-09
Device Publish Date2026-01-30

Devices Manufactured by Vantive US Healthcare LLC

57332414208016 - FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTION2026-02-09This device is a plastic disconnect cap for Automated Peritoneal Dialysis (APD) containing povidone-iodine.
57332414208016 - FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTION2026-02-09 This device is a plastic disconnect cap for Automated Peritoneal Dialysis (APD) containing povidone-iodine.
57332414208269 - Minicap2026-02-09 This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer
27332414207940 - LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER2025-10-01 This adapter is a double sealing female Luer lock adapter with a 2-piece, combination compression fit/barbed catheter connector.

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