CardioLabs Sirona
CardioLabs Sirona (RX22773-001) is a Class II device made by Datrix LLC, listed in FDA GUDID since 21 Feb 2017 (UDI-DI 00851074007248), registry data as of 22 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 | Number00851074007248 | Date21 Feb 2017 | StatusListed |
Official records
- AccessGUDID record 00851074007248
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- CardioLabs
- Generic name
- Telemetric electrocardiographic ambulatory recorder
- Model / Ref / Catalog
- Sirona, RX22773-001
- Primary DI / UDI-DI
- 00851074007248
- FDA product code
- MWJ
- GMDN term
- Telemetric electrocardiographic ambulatory recorder
- Device class
- Class II
- Regulation number
- 870.2800
- GUDID distribution status
- In Commercial Distribution
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