Identity
- Trade Name
- MEDCOMP TESIO CATHETERSMEDCOMP TESIO CATHETERS FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, implantable FDA UDI
- Device Name
- 10F X 70CM BIO-FLEX TESIO CATHETER KIT (ARTERIAL CUFF - 46CM FROM TIP) (VENOUS CUFF - 50CM FROM TIP) FDA UDI
- Model / Reference
- BFRD1070KD-A FDA UDI
- Description
- 10F X 70CM BIO-FLEX TESIO CATHETER KIT (ARTERIAL CUFF - 46CM FROM TIP) (VENOUS CUFF - 50CM FROM TIP) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884908129045 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
Medcomp Tesio Cathetersmedcomp Tesio Catheters 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 4a3915fb-e30c-4f1e-8b1b-e64d67a80f39 35 fields · synced Jun 6, 2026