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Sensor

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name
Sensor FDA UDI
Generic Name
Airway temperature monitoring system FDA UDI
Device Name
Airflow Sensor 1, Channel, Adult, Cannula Style FDA UDI
Model / Reference
AIR FLOW SENSOR 1 CH.ADULT CANN.STYLE FDA UDI
Description
Airflow Sensor 1, Channel, Adult, Cannula Style FDA UDI

Identifiers

Catalog Number
P1222 FDA UDI
Primary DI / UDI-DI
00606959009981 FDA UDI
510(k) Number
K913396 FDA UDI
FDA Product Code
BZG FDA UDI
GMDN Term
Airway temperature monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1840 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Airway temperature monitoring system

Sensor by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Airway temperature monitoring system.

Cleared under the same submission

K913396 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Respironics, Inc.

Sources (1)

  • FDA UDI 5f9b9202-32c2-4864-a4ae-6b83b092d9ef 37 fields · synced May 29, 2026