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Flex-Neck®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Flex-Neck® FDA UDI
Generic Name
Peritoneal dialysis catheter adaptor, single-use FDA UDI
Model / Reference
00884450305997 FDA UDI

Identifiers

Catalog Number
CE-1400/B FDA UDI
Primary DI / UDI-DI
00884450305997 FDA UDI
FDA Product Code
FJS FDA UDI
GMDN Term
Peritoneal dialysis catheter adaptor, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Peritoneal dialysis catheter adaptor, single-use

Flex-Neck is a single-use peritoneal dialysis catheter adaptor designed to connect incompatible dialysis devices, providing a secure and safe solution for patients undergoing long-term peritoneal dialysis. With its unique dual-piece design and FDA clearance, Flex-Neck is engineered to meet the highest standards of quality and performance.

Similar devices

Also classified as Peritoneal dialysis catheter adaptor, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI 5da9725c-105f-4698-bcaa-4f1d4d37d833 33 fields · synced Jul 10, 2026