Identity
- Trade Name
- DHF FDA UDI
- Generic Name
- Haemoconcentrator FDA UDI
- Model / Reference
- 02 HEMOCONCENTRATOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033178102933 FDA UDI
- 510(k) Number
- K021732 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Haemoconcentrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5860 FDA UDI
- Commercial Distribution
- 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
No
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
Category: Haemoconcentrator
Dhf by Sorin Group Italia Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemoconcentrator.
- CAPIOX® HEMOCONCENTRATOR — Terumo Corp. · Class II
- CAPIOX® HEMOCONCENTRATOR — Terumo Corp. · Class II
- CAPIOX® HEMOCONCENTRATOR — Terumo Corp. · Class II
- CAPIOX® HEMOCONCENTRATOR — Terumo Corp. · Class II
- DHF — SORIN GROUP ITALIA SRL · Class II
- SH — SORIN GROUP ITALIA SRL · Class II
Cleared under the same submission
K021732 also covers:
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
- Sorin Group Italia Srl
Sources (1)
- FDA UDI 1c7fb485-3251-4d87-8f39-9304efdf7825 33 fields · synced May 30, 2026