Identity
- Trade Name
- Zenysis Dual Lumen Acute Dialysis Catheter FDA UDI
- Generic Name
- Haemodialysis catheterization kit FDA UDI
- Device Name
- Zenysis DL, 24cm ST Kit FDA UDI
- Model / Reference
- A853240 FDA UDI
- Description
- Zenysis DL, 24cm ST Kit FDA UDI
Identifiers
- Catalog Number
- A853240 FDA UDI
- Primary DI / UDI-DI
- 00801741109768 FDA UDI
- FDA Product Code
- MPB FDA UDI
- GMDN Term
- Haemodialysis catheterization 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 Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 24 Centimeter FDA UDICatheter Gauge — 11 French FDA UDI
Zenysis Dual Lumen Acute Dialysis Catheter 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bard Access Systems, Inc.
Sources (1)
- FDA UDI d4d879c1-36e8-4fe2-a65e-a0ea9f7f19ec 37 fields · synced Jun 9, 2026