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Bio-Cath Central Venous Access Catheterbio-Cath Central Venous Access Catheter
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- BIO-CATH CENTRAL VENOUS ACCESS CATHETERBIO-CATH CENTRAL VENOUS ACCESS CATHETER FDA UDI
- Generic Name
- Centrally-inserted central venous catheter FDA UDI
- Device Name
- 9.5F X 90CM SINGLE LUMEN LT9.5F CVC BASIC KITCVC BASIC KIT FDA UDI
- Model / Reference
- MR28010919 FDA UDI
- Description
- 9.5F X 90CM SINGLE LUMEN LT9.5F CVC BASIC KITCVC BASIC KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884908034578 FDA UDI
- FDA Product Code
- LJS FDA UDI
- GMDN Term
- Centrally-inserted central venous catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5970 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Bio-Cath Central Venous Access Catheterbio-Cath Central Venous Access Catheter by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID
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
- Medical Components Inc
Sources (1)
- FDA UDI bfe6ccda-c433-43f6-951d-630826256b64 35 fields · synced May 31, 2026