Resp-O2 Oral Airways, Berman Type

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Resp-O2 Oral Airways, Berman Type FDA UDI
Generic Name: Oropharyngeal airway, single-use FDA UDI
Device Name: Each Kit Contains: 1-Infant (40 mm), 1-Child (60 mm),1-Small Adult (80 mm),1-Medium Adult (90 mm),1-Large Adult (100 mm),1-XL Adult (110 mm) FDA UDI
Model / Reference: 36312 FDA UDI
Description: Each Kit Contains: 1-Infant (40 mm), 1-Child (60 mm),1-Small Adult (80 mm),1-Medium Adult (90 mm),1-Large Adult (100 mm),1-XL Adult (110 mm) FDA UDI

Identifiers

Primary DI / UDI-DI: 00840117316010 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Oropharyngeal airway, single-use

Resp-O2 Oral Airways, Berman Type by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Dynarex Corp.

Sources (1)

FDA UDI 9ed3de60-5563-4f10-8a19-cad5a2202549 33 fields · synced May 31, 2026