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Aerogen® Professional Nebulizer System

FDA UDI

Class II (US FDA UDI)

by Aerogen, Inc.

Identity

Trade Name
Aerogen® Professional Nebulizer System FDA UDI
Generic Name
Therapeutic agent nebulizer, benchtop FDA UDI
Device Name
T-Piece neonate (P/N 10-123) and Plug (P/N 10-040) Assembly FDA UDI
Model / Reference
60-043 FDA UDI
Description
T-Piece neonate (P/N 10-123) and Plug (P/N 10-040) Assembly FDA UDI

Identifiers

Primary DI / UDI-DI
05391517933093 FDA UDI
510(k) Number
K021175 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Therapeutic agent nebulizer, 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

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Therapeutic agent nebulizer, benchtop

Aerogen® Professional Nebulizer System by Aerogen, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Therapeutic agent nebulizer, benchtop.

Cleared under the same submission

K021175 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aerogen, Inc.

Sources (1)

  • FDA UDI cca30e06-e5eb-449a-adca-b5c0542fcc3e 36 fields · synced Jun 8, 2026