Lma

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: LMA FDA UDI
Generic Name: Laryngeal mask airway, single-use FDA UDI
Device Name: LMA Fastrach™ ETT 8.0mm FDA UDI
Model / Reference: IPN922873 FDA UDI
Description: LMA Fastrach™ ETT 8.0mm FDA UDI

Identifiers

Catalog Number: 131080 FDA UDI
Primary DI / UDI-DI: 15060112318792 FDA UDI
FDA Product Code: BTR FDA UDI
GMDN Term: Laryngeal mask airway, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 8 Millimeter FDA UDI

Category: Laryngeal mask airway, single-use

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

Similar devices

Also classified as Laryngeal mask airway, single-use.

Laryseal Blue Laryngeal Mask Airway Slimline Pack Size 1.5 — FLEXICARE MEDICAL LIMITED · Class I
I-GEL PLUS, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG — Intersurgical Incorporated · Class I
Laryseal Clear Laryngeal Mask Airway Size 4 — FLEXICARE MEDICAL LIMITED · Class I
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 II	Pending data

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

Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI dd0cc181-e8e9-4bdb-8a82-26cc64d90428 37 fields · synced Jun 1, 2026