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Protekt Nebulizer

FDA UDI

Class II (US FDA UDI)

by Proactive Medical Products

Identity

Trade Name
Protekt Nebulizer FDA UDI
Generic Name
Therapeutic agent vaporizer, benchtop FDA UDI
Device Name
Protekt Pediatric Nebulizer w/ Disposable and Reusable Neb Kit, w/ Pediatric Mask - Blue Fish FDA UDI
Model / Reference
PMNEBRDK-BF FDA UDI
Description
Protekt Pediatric Nebulizer w/ Disposable and Reusable Neb Kit, w/ Pediatric Mask - Blue Fish FDA UDI

Identifiers

Catalog Number
PMNEBRDK-BF FDA UDI
Primary DI / UDI-DI
05060488573583 FDA UDI
510(k) Number
K123030 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Therapeutic agent vaporizer, benchtop 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Height — 8 Inch FDA UDI
Length — 6 Inch FDA UDI
Width — 9 Inch FDA UDI

Category: Therapeutic agent vaporizer, benchtop

Protekt Nebulizer by Proactive Medical Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Therapeutic agent vaporizer, benchtop.

Cleared under the same submission

K123030 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Proactive Medical Products

Sources (1)

  • FDA UDI 970dcbd7-2f9a-4afb-afe2-fb2713f07245 37 fields · synced May 30, 2026