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Lma

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
LMA FDA UDI
Generic Name
Suction oesophageal intubation detector, adult FDA UDI
Device Name
Esophageal Intubation Detector - Bulb FDA UDI
Model / Reference
IPN046010 FDA UDI
Description
Esophageal Intubation Detector - Bulb FDA UDI

Identifiers

Catalog Number
EID200 FDA UDI
Primary DI / UDI-DI
05060112313295 FDA UDI
510(k) Number
K990556 FDA UDI
FDA Product Code
BTR FDA UDI
GMDN Term
Suction oesophageal intubation detector, adult 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Suction oesophageal intubation detector, adult

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

Similar devices

Also classified as Suction oesophageal intubation detector, adult.

Cleared under the same submission

K990556 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 9fba79a6-5014-4fc4-92b2-b5d0ffcd6733 36 fields · synced May 30, 2026