Identity
- Trade Name
- CAREline FDA UDI
- Generic Name
- Haemodialysis system dialyser holder FDA UDI
- Device Name
- Dialyzer Holder Lock Sleeve FDA UDI
- Model / Reference
- 0450007 FDA UDI
- Description
- Dialyzer Holder Lock Sleeve FDA UDI
Identifiers
- Catalog Number
- 0450007 FDA UDI
- Primary DI / UDI-DI
- 00840861102075 FDA UDI
- FDA Product Code
- KOC FDA UDI
- GMDN Term
- Haemodialysis system dialyser holder 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haemodialysis system dialyser holder
CAREline by Fresenius Medical Care Renal Therapies Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis system dialyser holder.
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class I
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class I
- Universal Dialyzer Holder Clamp — Reprocessing Products Corp · Class I
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class I
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class I
- Universal Dialyzer Holder Clamp with Drip Chamber Post — Reprocessing Products Corp · Class I
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class I
- Molded Products, Inc. — MOLDED PRODUCTS 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
- Fresenius Medical Care Renal Therapies Group, LLC
Sources (1)
- FDA UDI b8be9e90-d20f-4f01-917b-5626d6cc4c6a 35 fields · synced May 29, 2026