Lma

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: LMA FDA UDI
Generic Name: Laryngeal mask airway, single-use FDA UDI
Device Name: LMA Unique® Airway Plus Pack Size 5 FDA UDI
Model / Reference: IPN029767 FDA UDI
Description: LMA Unique® Airway Plus Pack Size 5 FDA UDI

Identifiers

Catalog Number: V128050 FDA UDI
Primary DI / UDI-DI: 14026704665423 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Laryngeal mask airway, single-use

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

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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 f1a8861d-cdf8-4d77-99aa-62630db50def 36 fields · synced Jun 8, 2026