Resp-O2 Compressor Nebulizer Plus

FDA UDI

Class II (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Resp-O2 Compressor Nebulizer Plus FDA UDI
Generic Name: Nebulizing system delivery set, reusable FDA UDI
Device Name: Resp-O2 Compressor Nebulizer Plus; Contains 6ml Nebulizer bottle, adult mask, child mask, 7ft tube, mouth, 2-connector, 5 filters FDA UDI
Model / Reference: 5618 FDA UDI
Description: Resp-O2 Compressor Nebulizer Plus; Contains 6ml Nebulizer bottle, adult mask, child mask, 7ft tube, mouth, 2-connector, 5 filters FDA UDI

Identifiers

Primary DI / UDI-DI: 00616784561820 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Nebulizing system delivery set, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Nebulizing system delivery set, reusable

Resp-O2 Compressor Nebulizer Plus by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nebulizing system delivery set, reusable.

Omron Nosepiece for Nebulizer — Omron Healthcare, Inc. · Class II
Nasoneb® — MONAGHAN MEDICAL CORP. · Class I
Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II
Nebulizer Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
Schuco — Allied Medical LLC · Class II
Yirdoc — Qingdao Future Medical Technology Co., Ltd. · Class II
VixOne™ Reusable Nebulizer — WESTMED, INC. · Class II
Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II

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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Dynarex Corp.

Sources (1)

FDA UDI a86d34d8-4654-41ce-b37d-85794f99c622 33 fields · synced May 30, 2026