Identity
- Trade Name
- Flex-Neck® FDA UDI
- Generic Name
- Peritoneal dialysis catheter adaptor, single-use FDA UDI
- Model / Reference
- 00884450170052 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884450170052 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® by Merit Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peritoneal dialysis catheter adaptor, single-use.
- Safe-Lock® — Fresenius Medical Care Holdings, Inc. · Class II
- Peritoneal Dialysis Catheter Adapter — Medionics International , Ltd. · Class II
- Locking Cap for Peritoneal Dialysis Catheter Adapter — BAXTER INTERNATIONAL INC. · Class II
- stay.safe® — Fresenius Medical Care Holdings, Inc. · Class II
- Ritus — Mozarc Medical US LLC · Class II
- Argyle — Mozarc Medical US LLC · Class II
- Peritoneal Dialysis Catheter Adapter — Medionics International , Ltd. · Class II
- Locking Titanium Adapter for Peritoneal Dialysis Catheter — BAXTER INTERNATIONAL INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 16886616-a186-4cba-aa32-7b0ca1471417 32 fields · synced Jun 9, 2026