← Back to catalogue

Aerogen Solo Nebulizer System

FDA UDI

Class II (US FDA UDI)

by Aerogen, Inc.

Identity

Trade Name
Aerogen Solo Nebulizer System FDA UDI
Generic Name
Therapeutic agent nebulizer, benchtop FDA UDI
Device Name
Adult T-Piece Assembly FDA UDI
Model / Reference
60-074 FDA UDI
Description
Adult T-Piece Assembly FDA UDI

Identifiers

Primary DI / UDI-DI
05391517934311 FDA UDI
510(k) Number
K070642 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

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

Cleared under the same submission

K070642 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Aerogen, Inc.

Sources (1)

  • FDA UDI 228c7171-b124-4042-8e6e-23ee7bcc175e 37 fields · synced May 30, 2026