Macs

FDA UDI

Class II (US FDA UDI)

by Airon Corporation

Identity

Trade Name: MACS FDA UDI
Generic Name: Anaesthesia breathing circuit, single-use FDA UDI
Device Name: Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long with large mask and head strap each. FDA UDI
Model / Reference: 58011 FDA UDI
Description: Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long with large mask and head strap each. FDA UDI

Identifiers

Catalog Number: 58011 FDA UDI
Primary DI / UDI-DI: 00853678006078 FDA UDI
510(k) Number: K080692 FDA UDI
FDA Product Code: BTL FDA UDI
GMDN Term: Anaesthesia breathing circuit, single-use 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

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

Yes

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

Dimensions & Sizes

Size: Length — 72 Inch FDA UDI
Width — .86 Inch FDA UDI
Height — .86 Inch FDA UDI
Weight — .3125 Pound FDA UDI

Category: Anaesthesia breathing circuit, single-use

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

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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 38a38c35-2bb7-47f7-b017-0d9099f2a0a7 38 fields · synced May 30, 2026