Salter AIRE Elite - Salter AIRE Elite™ Compressor replacement filters - SALTER LABS

Duns Number:022721133

Device Description: Salter AIRE Elite™ Compressor replacement filters

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More Product Details

Catalog Number

8501-0-5

Brand Name

Salter AIRE Elite

Version/Model Number

8501-0-5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K870027

Product Code Details

Product Code

CCQ

Product Code Name

NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)

Device Record Status

Public Device Record Key

b8a07b48-3867-4ce9-917b-b8218ca7a164

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

February 09, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SALTER LABS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 865
2 A medical device with a moderate to high risk that requires special controls. 1134