Identity
- Trade Name
- Lifemed Chronic Tenckhoff Peritoneal Catheter FDA UDI
- Generic Name
- Peritoneal dialysis catheter, chronic FDA UDI
- Device Name
- Lifemed Chronic Tenckhoff Peritoneal Catheter with Radiopaque Stripe and Two Attached Cuffs FDA UDI
- Model / Reference
- PD3101 FDA UDI
- Description
- Lifemed Chronic Tenckhoff Peritoneal Catheter with Radiopaque Stripe and Two Attached Cuffs FDA UDI
Identifiers
- Catalog Number
- PD3101 FDA UDI
- Primary DI / UDI-DI
- 00852250006000 FDA UDI
- FDA Product Code
- FJS FDA UDI
- GMDN Term
- Peritoneal dialysis catheter, 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.69 Millimeter FDA UDILumen/Inner Diameter — 2.66 Millimeter FDA UDILength — 38 Centimeter FDA UDI
Category: Peritoneal dialysis catheter, chronic
Lifemed Chronic Tenckhoff Peritoneal Catheter by Lifemed of California — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peritoneal dialysis catheter, chronic.
- Flex-Neck® — Merit Medical Systems, Inc. · Class II
- Cook — COOK INCORPORATED · Class I
- Flex-Neck® — Merit Medical Systems, Inc. · Class II
- Flex-Neck® — Merit Medical Systems, Inc. · Class II
- Flex-Neck® — Merit Medical Systems, Inc. · Class II
- Cook — COOK INCORPORATED · Class I
- Cook — COOK INCORPORATED · Class I
- Flex-Neck® — Merit Medical Systems, 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
- Lifemed of California
Sources (1)
- FDA UDI a6272dcd-1f76-445a-9bdf-2e0fce848157 37 fields · synced Jun 8, 2026