Macs

FDA UDI

Class II (US FDA UDI)

by Airon Corporation

Identity

Trade Name: MACS FDA UDI
Generic Name: In-line CPAP set, nebulizing FDA UDI
Device Name: MACS CPAP System FDA UDI
Model / Reference: MACS CPAP System FDA UDI
Description: MACS CPAP System FDA UDI

Identifiers

Catalog Number: 20201 FDA UDI
Primary DI / UDI-DI: 00853678006030 FDA UDI
510(k) Number: K080692 FDA UDI
FDA Product Code: BTL FDA UDI
GMDN Term: In-line CPAP set, nebulizing FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5925 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Weight — 3 Pound FDA UDI
Depth — 8.2 Inch FDA UDI
Width — 3.7 Inch FDA UDI
Height — 6.7 Inch FDA UDI

Category: In-line CPAP set, nebulizing

Macs by Airon Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as In-line CPAP set, nebulizing.

VYGON — Vygon Corp. · Class II
Rescuer II Compact CPAP with Nebulizer Kit — B.L.S. Systems Limited · Class II
CARevent CPAP — O-Two Medical Technologies Inc · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class II
Rescuer II Compact CPAP System with Small Deluxe CPAP Mask and Nebulizer Kit — B.L.S. Systems Limited · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class II

Cleared under the same submission

K080692 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: Airon Corporation

Sources (1)

FDA UDI 007479be-0113-4f8d-bc61-221d9f300211 38 fields · synced May 30, 2026