Vermax PG-IRT1602
Vermax PG-IRT1602 is an infrared patient thermometer (FDA Class II; FDA product code FLL, Thermometer, Electronic, Clinical) made by Coastalaware Holdings Inc, cleared under FDA 510(k) K182597 on 3 Apr 2019 and listed in FDA GUDID since 8 Jan 2021 (UDI-DI G025PGIRT16020), 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 | NumberG025PGIRT16020 | Date8 Jan 2021 | StatusListed |
| United States | FDA 510(k) | NumberK182597 | Date3 Apr 2019 | StatusActive |
Official records
- AccessGUDID record 00628678770188
- FDA 510(k) database K182597
Across registries
- FDA 510(k) K182597 decided 3 Apr 2019 Active
- FDA GUDID UDI-DI G025PGIRT16020 listed 8 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K182597
- Listed FDA GUDID G025PGIRT16020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vermax
- Generic name
- Infrared patient thermometer, skin
- Model / reference
- PG-IRT1602
- Primary DI / UDI-DI
- G025PGIRT16020, 00628678770188
- 510(k) Number
- FDA product code
- FLL
- GMDN term
- Infrared patient thermometer, skin
- Device class
- Class II
- Regulation number
- 880.2910
- GUDID distribution status
- In Commercial Distribution (UDI-DI G025PGIRT16020)Not in Commercial Distribution (UDI-DI 00628678770188)
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