Oxygen Sensor

FDA UDI

Class II (US FDA UDI)

by Honeywell Healthcare Solutions GmbH

Identity

Trade Name: Oxygen Sensor FDA UDI
Generic Name: Respiratory oxygen sensor FDA UDI
Device Name: Oxygen Sensor OOM202-2R / REF 27935 FDA UDI
Model / Reference: OOM202-2R FDA UDI
Description: Oxygen Sensor OOM202-2R / REF 27935 FDA UDI

Identifiers

Catalog Number: E1001685 FDA UDI
Primary DI / UDI-DI: 04036616009102 FDA UDI
510(k) Number: K082655 FDA UDI
FDA Product Code: CCL FDA UDI
GMDN Term: Respiratory oxygen sensor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1720 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 23 Gram FDA UDI
Height — 28 Millimeter FDA UDI
Width — 29 Millimeter FDA UDI

Category: Respiratory oxygen sensor

Oxygen Sensor by Honeywell Healthcare Solutions GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Respiratory oxygen sensor.

Vapotherm — Vapotherm Inc. · Class II
Vapotherm — Vapotherm Inc. · Class II
Artema Anesthetic Oxygen (O2) Sensor — Philips DS North America LLC · Class II
MAX-13 SENSOR, PRECISION MEDICAL 504877 — Maxtec, Inc. · Class II
Vapotherm — Vapotherm Inc.
Analytical Industries Inc. — ANALYTICAL INDUSTRIES, INC. · Class II
6600-1278-600 — City Technology Limited · Class II
Vapotherm — Vapotherm Inc.

Cleared under the same submission

K082655 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Honeywell Healthcare Solutions GmbH

Sources (1)

FDA UDI 0f504b89-9261-4418-8c31-1c7984230fab 38 fields · synced May 30, 2026