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Medline

FDA UDI

Class I (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
MEDLINE FDA UDI
Generic Name
Oropharyngeal airway, reusable FDA UDI
Device Name
GUEDEL AIRWAY PACK, EIGHT SIZES FDA UDI
Model / Reference
DYNDPACK8 FDA UDI
Description
GUEDEL AIRWAY PACK, EIGHT SIZES FDA UDI

Identifiers

Catalog Number
DYNDPACK8 FDA UDI
Primary DI / UDI-DI
20197344137234 FDA UDI
FDA Product Code
CAE FDA UDI
GMDN Term
Oropharyngeal airway, reusable 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

No

FDA UDI

Category: Oropharyngeal airway, reusable

Medline by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oropharyngeal airway, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 79619ebc-166b-45dc-98ed-12c60a4582dc 36 fields · synced May 30, 2026