Identity
- Trade Name
- DIACLEAR FDA UDI
- Generic Name
- Intravenous line filter FDA UDI
- Device Name
- The DIACLEAR ultrafilter is intended to be used only with either HOSPAL Integra or Innova or GAMBRO Phonenix dialysis machines. It is indicated for purification of dialysis fluid to obtain microbiologically high quality dialysis fluid. FDA UDI
- Model / Reference
- 106887 FDA UDI
- Description
- The DIACLEAR ultrafilter is intended to be used only with either HOSPAL Integra or Innova or GAMBRO Phonenix dialysis machines. It is indicated for purification of dialysis fluid to obtain microbiologically high quality dialysis fluid. FDA UDI
Identifiers
- Catalog Number
- 106887 FDA UDI
- Primary DI / UDI-DI
- 07332414066314 FDA UDI
- 510(k) Number
- K003957 FDA UDI
- FDA Product Code
- FIP FDA UDI
- GMDN Term
- Intravenous line filter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5665 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
Yes
FDA UDI
Category: Intravenous line filter
Diaclear by Gambro Industries — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Gambro Industries
Sources (1)
- FDA UDI df402d02-62f8-489c-93e0-af4d91712868 37 fields · synced Jun 8, 2026