Identity
- Trade Name
- Crit-Line® FDA UDI
- Generic Name
- Haemodialysis system blood volume monitor FDA UDI
- Device Name
- Blood Chamber II FDA UDI
- Model / Reference
- 191058 FDA UDI
- Description
- Blood Chamber II FDA UDI
Identifiers
- Catalog Number
- 191058 FDA UDI
- Primary DI / UDI-DI
- 00840861102020 FDA UDI
- 510(k) Number
- K160749 FDA UDI
- FDA Product Code
- KOC FDA UDI
- GMDN Term
- Haemodialysis system blood volume monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 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
Yes
FDA UDI
Category: Haemodialysis system blood volume monitor
Crit-Line® by Fresenius Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis system blood volume monitor.
- Crit-Line® — Fresenius Medical Care Holdings, Inc. · Class II
- Crit-Line® — Fresenius Medical Care Holdings, Inc. · Class II
- Crit-Line® — Fresenius Usa, Inc. · Class II
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
- Fresenius Usa, Inc.
Sources (1)
- FDA UDI a8ddb937-dbba-418b-9437-b2d69f5b11aa 37 fields · synced May 30, 2026