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Microstream

FDA UDI

Class II (US FDA UDI)

by Oridion Medical 1987 Ltd.

Identity

Trade Name
Microstream FDA UDI
Generic Name
Carbon dioxide monitor FDA UDI
Device Name
PM35MN-RR, with Microstream and Nellcor SPO2 Technologies, with Nellcor RR and SPD FDA UDI
Model / Reference
PM35MN02-RR FDA UDI
Description
PM35MN-RR, with Microstream and Nellcor SPO2 Technologies, with Nellcor RR and SPD FDA UDI

Identifiers

Primary DI / UDI-DI
10884521761216 FDA UDI
510(k) Number
K200594 FDA UDI
FDA Product Code
CCK FDA UDI
GMDN Term
Carbon dioxide monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Carbon dioxide monitor

Microstream by Oridion Medical 1987 Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carbon dioxide monitor.

Cleared under the same submission

K200594 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oridion Medical 1987 Ltd.

Sources (1)

  • FDA UDI f0d20681-9d78-4f97-b850-592c0d7cabe6 35 fields · synced May 31, 2026