Identity
- Trade Name
- BIO-FLEX® TESIO® FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, implantable FDA UDI
- Device Name
- 10FX52CM SINGLE BIO-FLEX® TESIO® VENOUS CATHETER TRAY (CUFF 21.2CM FROM TIP) FDA UDI
- Model / Reference
- DBFSS FDA UDI
- Description
- 10FX52CM SINGLE BIO-FLEX® TESIO® VENOUS CATHETER TRAY (CUFF 21.2CM FROM TIP) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884908145922 FDA UDI
- FDA Product Code
- MSD FDA UDI
- GMDN Term
- Double-lumen haemodialysis catheter, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5540 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
MR Conditional FDA UDI
Bio-Flex® Tesio® by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 d578b99d-6534-4744-ad03-492daec56ab6 35 fields · synced Jun 6, 2026