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Vital Signs™

FDA UDI

Class I (US FDA UDI)

by Airlife, Inc.

Identity

Trade Name
Vital Signs™ FDA UDI
Generic Name
Oropharyngeal airway, single-use FDA UDI
Device Name
Vital Signs™ Oral Airway Guedel FDA UDI
Model / Reference
3580EU FDA UDI
Description
Vital Signs™ Oral Airway Guedel FDA UDI

Identifiers

Catalog Number
3580EU FDA UDI
Primary DI / UDI-DI
10190752131613 FDA UDI
FDA Product Code
CAE FDA UDI
GMDN Term
Oropharyngeal 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Oropharyngeal airway, single-use

Vital Signs™ by Airlife, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oropharyngeal airway, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Airlife, Inc.

Sources (1)

  • FDA UDI 4e4d62e7-aa1d-48ac-ab4d-8c93f523f343 35 fields · synced Jun 8, 2026