IntelAir

FDA UDI

Class II (US FDA UDI)

by Applied Medical Technology, Inc.

Identity

Trade Name: IntelAir FDA UDI
Generic Name: Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
Device Name: IntelAir, Tape Secured, with O2/CO2 Tubes, 26F x 11 cm (Pouch) FDA UDI
Model / Reference: EIA-21-2611 FDA UDI
Description: IntelAir, Tape Secured, with O2/CO2 Tubes, 26F x 11 cm (Pouch) FDA UDI

Identifiers

Catalog Number: EIA-21-2611, IA-21-2611-05 FDA UDI
Primary DI / UDI-DI: 00842071131920 FDA UDI
510(k) Number: K142467 FDA UDI
FDA Product Code: CCK FDA UDI
GMDN Term: Nasal oxygen cannula, carbon-dioxide-sampling 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 11 Centimeter FDA UDI

Category: Nasal oxygen cannula, carbon-dioxide-sampling

IntelAir by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nasal oxygen cannula, carbon-dioxide-sampling.

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Microstream Advance — ORIDION MEDICAL 1987 LTD. · Class II
Omnistream — ORIDION MEDICAL 1987 LTD. · Class II
Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II

Cleared under the same submission

K142467 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: Applied Medical Technology, Inc.

Sources (1)

FDA UDI 28b44463-8bda-430f-9b5e-b2070f63a4c4 37 fields · synced Jun 9, 2026