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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
00884450170038 FDA UDI

Identifiers

Primary DI / UDI-DI
00884450170038 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 peritoneal dialysis catheter adaptor designed for single-use use in patients undergoing long-term indwelling catheterization. This FDA-cleared connecting device enables the safe and effective exchange of dialysate between the catheter and the dialysis line, reducing the risk of catheter occlusion and infection.

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 a2c63832-7f97-41c5-8131-6ac856078e4b 32 fields · synced Jul 11, 2026