APA™ O2 MAC 4 Blade

FDA UDI

Class I (US FDA UDI)

by Venner Medical (singapore) Pte. Ltd.

Identity

Trade Name: APA™ O2 MAC 4 Blade FDA UDI
Generic Name: Laryngoscope blade, single-use FDA UDI
Device Name: The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxygen tube adaptor/holder and tubing to provide supplemental oxygen to the patient when using the Venner APA Video Laryngoscope. FDA UDI
Model / Reference: 700340 FDA UDI
Description: The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxygen tube adaptor/holder and tubing to provide supplemental oxygen to the patient when using the Venner APA Video Laryngoscope. FDA UDI

Identifiers

Catalog Number: 700340 FDA UDI
Primary DI / UDI-DI: 08885009190332 FDA UDI
510(k) Number: K191602 FDA UDI
FDA Product Code: BYX FDA UDI
CCW FDA UDI
GMDN Term: Laryngoscope blade, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5860 FDA UDI
868.5540 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Laryngoscope blade, single-use

APA™ O2 MAC 4 Blade by Venner Medical (singapore) Pte. Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Laryngoscope blade, single-use.

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Disposable Conventional Laryngoscope Blade — Maco International · Class I

Cleared under the same submission

K191602 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 I	Pending data

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Manufacturer

Manufacturer: Venner Medical (singapore) Pte. Ltd.

Sources (1)

FDA UDI f383a028-62c2-4af3-885c-42245c638b8d 35 fields · synced May 30, 2026