softFlow 40620040
softFlow 40620040 is a Class II device made by Tni Medical AG, listed in FDA GUDID since 15 Mar 2021 (UDI-DI 04059163000545), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04059163000545 | Date15 Mar 2021 | StatusListed |
Official records
- AccessGUDID record 04059163000545
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- softFlow
- Generic name
- Inspiratory line humidification chamber, single-use
- Model / Ref / Catalog
- 40620040
- Primary DI / UDI-DI
- 04059163000545
- FDA product code
- BTT
- GMDN term
- Inspiratory line humidification chamber, single-use
- Device class
- Class II
- Regulation number
- 868.5450
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under Inspiratory line humidification chamber, single-use.