Identity
- Trade Name
- Catheter Repair Kit FDA UDI
- Generic Name
- Central venous catheter repair kit FDA UDI
- Device Name
- DUET CATHETER REPAIR KIT FDA UDI
- Model / Reference
- 5581000 FDA UDI
- Description
- DUET CATHETER REPAIR KIT FDA UDI
Identifiers
- Catalog Number
- 5581000 FDA UDI
- Primary DI / UDI-DI
- 00801741012464 FDA UDI
- FDA Product Code
- MSD FDA UDI
- GMDN Term
- Central venous catheter repair kit 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
No
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
Catheter Repair Kit by Bard Access Systems, 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
- Bard Access Systems, Inc.
Sources (1)
- FDA UDI bd588121-1780-49ed-bd87-1042f31dee1e 36 fields · synced Jun 9, 2026