FIRST STEP CIRRUS - FirstStep Select Cirrus, Overlay - Arjohuntleigh AB

Duns Number:355804758

Device Description: FirstStep Select Cirrus, Overlay

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More Product Details

Catalog Number

-

Brand Name

FIRST STEP CIRRUS

Version/Model Number

203604-RF

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FNM

Product Code Name

MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Record Status

Public Device Record Key

4e6bf957-86ed-4d53-9c5f-cbd1da6d70c9

Public Version Date

August 01, 2022

Public Version Number

3

DI Record Publish Date

January 31, 2017

Additional Identifiers

Package DI Number

15055982784884

Quantity per Package

3

Contains DI Package

05055982784887

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ARJOHUNTLEIGH AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 420
2 A medical device with a moderate to high risk that requires special controls. 840