Asi Co2-O2

FDA UDI

Class II (US FDA UDI)

by Maxtec, Inc.

Identity

Trade Name: ASI CO2-O2 FDA UDI
Generic Name: Respiratory oxygen sensor FDA UDI
Device Name: Air Systems International Oxygen Sensor FDA UDI
Model / Reference: T155P10-001 FDA UDI
Description: Air Systems International Oxygen Sensor FDA UDI

Identifiers

Primary DI / UDI-DI: 00853061006722 FDA UDI
510(k) Number: K963415 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

FDA UDI

Category: Respiratory oxygen sensor

Asi Co2-O2 by Maxtec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Oxygen Sensor — Honeywell Healthcare Solutions GmbH · Class II
Vapotherm — Vapotherm Inc.
Analytical Industries Inc. — ANALYTICAL INDUSTRIES, INC. · Class II
6600-1278-600 — City Technology Limited · Class II
Vapotherm — Vapotherm Inc.

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: Maxtec, Inc.

Sources (1)

FDA UDI 0cbdf685-ec11-45f2-9a07-1d75226736cd 34 fields · synced May 29, 2026