Identity
- Trade Name
- Peritoneal Dialysis Catheter FDA UDI
- Generic Name
- Peritoneal dialysis catheter, acute/chronic FDA UDI
- Model / Reference
- CA-1162 FDA UDI
Identifiers
- Catalog Number
- CA-1162 FDA UDI
- Primary DI / UDI-DI
- 00792079000219 FDA UDI
- 510(k) Number
- K993149 FDA UDI
- FDA Product Code
- FJS FDA UDI
- GMDN Term
- Peritoneal dialysis catheter, acute/chronic 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
Yes
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
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, acute/chronic
Peritoneal Dialysis Catheter by Medionics International , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peritoneal dialysis catheter, acute/chronic.
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- I-SERIES PD Catheter — MEDICAL COMPONENTS INC · Class II
- I-SERIES PD CATHETER — MEDICAL COMPONENTS INC · Class II
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- I-SERIES PD CATHETER — MEDICAL COMPONENTS INC · Class II
- I-SERIES PD Catheter — MEDICAL COMPONENTS INC · Class II
Cleared under the same submission
K993149 also covers:
- Peritoneal Dialysis Catheter — Medionics International , Ltd.
- Peritoneal Dialysis Catheter — Medionics International , Ltd.
- Peritoneal Dialysis Catheter — Medionics International , Ltd.
- Peritoneal Dialysis Catheter — Medionics International , Ltd.
- Peritoneal Dialysis Catheter — Medionics International , Ltd.
- Peritoneal Dialysis Catheter — Medionics International , Ltd.
- Peritoneal Dialysis Catheter — Medionics International , Ltd.
- Peritoneal Dialysis Catheter — Medionics International , Ltd.
- Peritoneal Dialysis Catheter — Medionics International , Ltd.
- Peritoneal Dialysis Catheter — Medionics International , Ltd.
- Peritoneal Dialysis Catheter — Medionics International , Ltd.
- Peritoneal Dialysis Catheter — Medionics International , Ltd.
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
- Medionics International , Ltd.
Sources (1)
- FDA UDI 9b196859-d8ca-4d3d-b36e-07d6f973d2c8 34 fields · synced Jun 8, 2026