Reusable Silicone Laryngeal Airway Mask

FDA UDI

Class I (US FDA UDI)

by Besmed Health Business Corp.

Identity

Trade Name: REUSABLE SILICONE LARYNGEAL AIRWAY MASK FDA UDI
Generic Name: Oropharyngeal airway, reusable FDA UDI
Device Name: REUSABLE SILICONE LARYNGEAL AIRWAY MASK SIZE: 2.0; AMBU Code:340200000 FDA UDI
Model / Reference: LA-77320 FDA UDI
Description: REUSABLE SILICONE LARYNGEAL AIRWAY MASK SIZE: 2.0; AMBU Code:340200000 FDA UDI

Identifiers

Primary DI / UDI-DI: 04716770773209 FDA UDI
FDA Product Code: CAE FDA UDI
GMDN Term: Oropharyngeal airway, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5110 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Oropharyngeal airway, reusable

Reusable Silicone Laryngeal Airway Mask by Besmed Health Business Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oropharyngeal airway, reusable.

ADC® — American Diagnostic Corporation · Class I
ADC® — American Diagnostic Corporation · Class I
Grafco — GF Health Products, Inc · Class I
EndoMask Elite® — MERLYN ASSOCIATES, INC. · Class I
ADC® — American Diagnostic Corporation · Class I
EndoMask Elite® — MERLYN ASSOCIATES, INC. · Class I
ADC® — American Diagnostic Corporation · Class I
MEDLINE — MEDLINE INDUSTRIES, INC. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Besmed Health Business Corp.

Sources (1)

FDA UDI d49495ac-17d8-4d2e-a37b-7d5035006df7 33 fields · synced Jun 8, 2026