LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER 5C4129

GUDID 27332414207940

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.

Vantive US Healthcare LLC

Peritoneal dialysis catheter adaptor, single-use

• Primary Device ID: 27332414207940
• NIH Device Record Key: 011c2f43-73af-4f39-8e38-97f42cd9272c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER
• Version Model Number: 5C4129
• Catalog Number: 5C4129
• Company DUNS: 119181963
• Company Name: Vantive US Healthcare LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)553-6898
• Email: osr.largo@vantive.com
• Phone: +1(800)553-6898
• Email: osr.largo@vantive.com
• Phone: +1(800)553-6898
• Email: osr.largo@vantive.com
• Phone: +1(800)553-6898
• Email: osr.largo@vantive.com
• Phone: +1(800)553-6898
• Email: osr.largo@vantive.com
• Phone: +1(800)553-6898
• Email: osr.largo@vantive.com
• Phone: +1(800)553-6898
• Email: osr.largo@vantive.com
• Phone: +1(800)553-6898
• Email: osr.largo@vantive.com
• Phone: +1(800)553-6898
• Email: osr.largo@vantive.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412007403 [Previous]
GS1	07332414207946 [Primary]
GS1	27332414207940 [Package]; Contains: 07332414207946; Package: PACK [5 Units]; In Commercial Distribution
GS1	57332414207941 [Package]; Package: CASE [39 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152675

FDA Product Code

• KDJ: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-01
• Device Publish Date: 2025-09-23

Devices Manufactured by Vantive US Healthcare LLC

• 57332414208016 - FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTION: 2026-02-09 This device is a plastic disconnect cap for Automated Peritoneal Dialysis (APD) containing povidone-iodine.
• 57332414208269 - Minicap: 2026-02-09 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 CATHETER: 2025-10-01This 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.
• 27332414207940 - LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER: 2025-10-01 This adapter is a double sealing female Luer lock adapter with a 2-piece, combination compression fit/barbed catheter connector.