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Hauge ll Airway Conscious Sedation Kit

FDA UDI

Class I (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name
Hauge ll Airway Conscious Sedation Kit FDA UDI
Generic Name
Oesophageal-obturating/tracheal airway, single-use FDA UDI
Device Name
Hauge ll Airway Conscious Sedation Kit with 7' Co2/O2 line with , male luer connectors, headstrap, tongue depressor, 2" pigtail with female luer FDA UDI
Model / Reference
6595 FDA UDI
Description
Hauge ll Airway Conscious Sedation Kit with 7' Co2/O2 line with , male luer connectors, headstrap, tongue depressor, 2" pigtail with female luer FDA UDI

Identifiers

Primary DI / UDI-DI
00709078011573 FDA UDI
FDA Product Code
CAE FDA UDI
GMDN Term
Oesophageal-obturating/tracheal 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Oesophageal-obturating/tracheal airway, single-use

Hauge ll Airway Conscious Sedation Kit by Westmed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oesophageal-obturating/tracheal airway, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Westmed, Inc.

Sources (1)

  • FDA UDI c40f8b97-7842-4ed8-863d-641eeaec57e6 33 fields · synced Jun 8, 2026