Proneb Max

FDA UDI

Class II (US FDA UDI)

by Pari Respiratory Equipment, Inc.

Identity

Trade Name: Proneb Max FDA UDI
Generic Name: Nebulizing system delivery set, reusable FDA UDI
Device Name: Proneb Max, 5 Yr, LC Sprint FDA UDI
Model / Reference: 130F35-LCS FDA UDI
Description: Proneb Max, 5 Yr, LC Sprint FDA UDI

Identifiers

Catalog Number: na FDA UDI
Primary DI / UDI-DI: 00744229130017 FDA UDI
510(k) Number: K191270 FDA UDI
FDA Product Code: CAF FDA UDI
BTI FDA UDI
GMDN Term: Nebulizing system delivery set, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 FDA UDI
868.6250 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Nebulizing system delivery set, reusable

Proneb Max by Pari Respiratory Equipment, Inc. — 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
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
Portable Mesh Nebulizer — FEELLIFE HEALTH INC. · Class II
Yirdoc — Qingdao Future Medical Technology Co., Ltd. · Class II

Cleared under the same submission

K191270 also covers:

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

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Manufacturer

Manufacturer: Pari Respiratory Equipment, Inc.

Sources (1)

FDA UDI f7f17033-f956-4615-a2bb-8e0ceb03cb44 35 fields · synced Jun 6, 2026