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Lma

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
LMA FDA UDI
Generic Name
Laryngeal mask airway, reusable FDA UDI
Device Name
LMA Fastrach Size 5 FDA UDI
Model / Reference
IPN047996 FDA UDI
Description
LMA Fastrach Size 5 FDA UDI

Identifiers

Catalog Number
13150 FDA UDI
Primary DI / UDI-DI
05060112311819 FDA UDI
510(k) Number
K051993 FDA UDI
FDA Product Code
BTR FDA UDI
GMDN Term
Laryngeal mask airway, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laryngeal mask airway, reusable

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

Similar devices

Also classified as Laryngeal mask airway, reusable.

Cleared under the same submission

K051993 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 9525d9d7-5485-45ad-9d88-83ef5e93e3e9 36 fields · synced Jun 8, 2026