Lma Airway Management

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: LMA AIRWAY MANAGEMENT FDA UDI
Generic Name: Laryngeal mask airway, single-use FDA UDI
Device Name: LMA UNIQUE (SILICONE CUFF) SIZE 5 FDA UDI
Model / Reference: IPN922781 FDA UDI
Description: LMA UNIQUE (SILICONE CUFF) SIZE 5 FDA UDI

Identifiers

Catalog Number: 105300-000050 FDA UDI
Primary DI / UDI-DI: 15060112317924 FDA UDI
FDA Product Code: CAE FDA UDI
GMDN Term: Laryngeal mask airway, single-use 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Laryngeal mask airway, single-use

Lma Airway Management by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Laryngeal mask airway, single-use.

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Laryngeal Mask Airway — HENAN TUOREN MEDICAL DEVICE CO., LTD. · Class IIa
SourceMark — SOURCEMARK, LLC. · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I
Disposable Laryngeal Mask Airway — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
Disposable Laryngeal Mask Airway — ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. · Class IIa

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: Teleflex Incorporated

Sources (1)

FDA UDI 4a8ff8a4-38b3-4820-9fde-2000fdaa48ee 36 fields · synced Jun 6, 2026