ViSi Chest Sensor Securements, 3M (Qty 100)
ViSi Chest Sensor Securements, 3M (Qty 100) (94-10012) is a Class II device made by Sotera Wireless, cleared under FDA 510(k) K152341 on 14 Dec 2015 and listed in FDA GUDID since 24 Jun 2020 (UDI-DI 10850733007305), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10850733007305 | Date24 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152341 | Date14 Dec 2015 | StatusActive |
Official records
- AccessGUDID record 10850733007305
- FDA 510(k) database K152341
Across registries
- FDA 510(k) K152341 decided 14 Dec 2015 Active
- FDA GUDID UDI-DI 10850733007305 listed 24 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K152341
- Listed FDA GUDID 10850733007305
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ViSi
- Generic name
- Dressing-fixation skin adhesive tape, non-silicone
- Model / Ref / Catalog
- Chest Sensor Securements, 3M (Qty 100), 94-10012
- Primary DI / UDI-DI
- 10850733007305
- 510(k) Number
- FDA product code
- MWI
- GMDN term
- Dressing-fixation skin adhesive tape, non-silicone
- Device class
- Class II
- Regulation number
- 870.2300
- GUDID distribution status
- In Commercial Distribution