Identity
- Trade Name
- softFlow FDA UDI
- Generic Name
- Inspiratory line humidification chamber, single-use FDA UDI
- Device Name
- Humidifier Rack Clinic softFlow FDA UDI
- Model / Reference
- 40641107 FDA UDI
- Description
- Humidifier Rack Clinic softFlow FDA UDI
Identifiers
- Catalog Number
- 40641107 FDA UDI
- Primary DI / UDI-DI
- 04059163000224 FDA UDI
- FDA Product Code
- BTT FDA UDI
- GMDN Term
- Inspiratory line humidification chamber, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Inspiratory line humidification chamber, single-use
softFlow by Tni Medical AG — 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
- Tni Medical AG
Sources (1)
- FDA UDI 40816f49-72b5-4b16-8007-1b748b002cdc 36 fields · synced May 30, 2026