Identity
- Trade Name
- Merit Medical® FDA UDI
- Generic Name
- Peritoneal dialysis catheter introduction set FDA UDI
- Model / Reference
- 00884450426340 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884450426340 FDA UDI
- FDA Product Code
- FCY FDA UDI
- GMDN Term
- Peritoneal dialysis catheter introduction set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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 introduction set
Merit Medical offers a comprehensive Peritoneal Dialysis catheter introduction set for patients requiring percutaneous placement of a peritoneal dialysis catheter. This single-use device is designed to assist with catheter insertion and may include additional support devices.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 898998bd-2eab-4ffb-923d-c417e45e792f 32 fields · synced Jul 11, 2026