Resp-O2 Dry Bubble Humidifier, 400 mL, 6 PSI (Home Use)

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Resp-O2 Dry Bubble Humidifier,400 mL,6 PSI (Home Use) FDA UDI
Generic Name: Non-heated respiratory humidifier FDA UDI
Model / Reference: 34221 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840117308855 FDA UDI
FDA Product Code: KFZ FDA UDI
GMDN Term: Non-heated respiratory humidifier FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5460 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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: Non-heated respiratory humidifier

Resp-O2 Dry Bubble Humidifier, 400 mL, 6 PSI (Home Use) by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-heated respiratory humidifier.

Bubble Humidifier — WESTMED, INC. · Class I
SENSIMEDICAL Sterile Water for Inhalation, USP — Sensimedical LLC · Class II
NanoVi — Eng3 Corporation · Class I
B&F — Allied Medical LLC · Class II
Bubble Humidifier — WESTMED, INC. · Class I
B&F — Allied Medical LLC · Class II
Chemtron — Allied Medical LLC · Class II
Procure — Twin Med, LLC · Class I

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 7e0816c6-3ecd-4088-8042-75d564fda01d 32 fields · synced May 30, 2026