Identity
- Trade Name
- Merit® Kit FDA UDI
- Generic Name
- Peritoneal dialysis catheter introduction set FDA UDI
- Model / Reference
- 00884450328606 FDA UDI
Identifiers
- Catalog Number
- K14-00077 FDA UDI
- Primary DI / UDI-DI
- 00884450328606 FDA UDI
- FDA Product Code
- PEV FDA UDI
- GMDN Term
- Peritoneal dialysis catheter introduction set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 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
No
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
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
This comprehensive Peritoneal dialysis catheter introduction set includes a collection of sterile devices, including invasive devices and non-dedicated support devices, to assist percutaneous placement of a peritoneal dialysis catheter. With its single-use design, this kit is intended for use in the dialysis process.
Similar devices
Also classified as Peritoneal dialysis catheter introduction set.
- Argyle — Mozarc Medical US LLC · Class I
- Ritus — Mozarc Medical US LLC · Class I
- Argyle — Mozarc Medical US LLC · Class I
- Ritus — Mozarc Medical US LLC · Class II
- Merit® Kit — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class I
- Merit® Kit — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI fe87e03c-d0a6-49dc-be82-7367f285fbe9 34 fields · synced Jul 24, 2026