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UltraStream Chronic Dialysis Catheter Peel Away Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- UltraStream Chronic Dialysis Catheter Peel Away Kit FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, implantable FDA UDI
- Device Name
- UltraStream Chronic Dialysis Catheter Peel Away Kit 15.5F x 40cm FDA UDI
- Model / Reference
- 32401540 FDA UDI
- Description
- UltraStream Chronic Dialysis Catheter Peel Away Kit 15.5F x 40cm FDA UDI
Identifiers
- Catalog Number
- 32401540 FDA UDI
- Primary DI / UDI-DI
- 00886333222865 FDA UDI
- 510(k) Number
- K102043 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
Yes
FDA UDI
UltraStream Chronic Dialysis Catheter Peel Away Kit by Argon Medical Devices, 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
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI e3de690a-2df3-444b-b13e-cc93e86026b3 38 fields · synced Jun 9, 2026