Microstream PM35MN05
Microstream PM35MN05 is a Class II device made by Oridion Medical 1987 Ltd., cleared under FDA 510(k) K200594 on 27 Apr 2020 (1 earlier submission) and listed in FDA GUDID since 25 Jan 2021 (UDI-DI 10884521741997), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884521741997 | Date25 Jan 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200594 | Date27 Apr 2020 | StatusActive |
Official records
- AccessGUDID record 10884521741997
- FDA 510(k) database K200594
- FDA 510(k) database K150272
Across registries
- FDA 510(k) K200594 decided 27 Apr 2020 Active
- FDA GUDID UDI-DI 10884521741997 listed 25 Jan 2021 Listed
Recalls
-
- Ongoing Z-0515-2021
The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm.
Timeline
- Cleared FDA 510(k) K150272
- Cleared FDA 510(k) K200594
- Recall initiated FDA recalls Z-0515-2021
- Listed FDA GUDID 10884521741997
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Microstream
- Generic name
- Carbon dioxide monitor
- Model / reference
- PM35MN05
- Primary DI / UDI-DI
- 10884521741997
- FDA product code
- CCK
- GMDN term
- Carbon dioxide monitor
- Device class
- Class II
- Regulation number
- 868.1400
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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