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Salter AIRE Elite

FDA UDI

Class II (US FDA UDI)

by Salter Labs

Identity

Trade Name
Salter AIRE Elite FDA UDI
Generic Name
Therapeutic agent nebulizer, benchtop FDA UDI
Device Name
Salter AIRE Elite Compressor with Nebulizers (2) 8960 FDA UDI
Model / Reference
SO-1985GN FDA UDI
Description
Salter AIRE Elite Compressor with Nebulizers (2) 8960 FDA UDI

Identifiers

Catalog Number
SO-1985GN FDA UDI
Primary DI / UDI-DI
00607411918360 FDA UDI
510(k) Number
K961476 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Therapeutic agent nebulizer, benchtop

Salter AIRE Elite by Salter Labs — 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

K961476 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Salter Labs

Sources (1)

  • FDA UDI f4a9b692-015b-4b95-9fc2-8eb710ed4e9c 37 fields · synced Jun 1, 2026