SelectAir - MEDTECH AIR COMPLETE SYSTEM W/MEDTECH STD PUMP - MOXI ENTERPRISES, LLC

Duns Number:958807575

Device Description: MEDTECH AIR COMPLETE SYSTEM W/MEDTECH STD PUMP AND SELECT PROTECT W/NYLON COVER

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More Product Details

Catalog Number

-

Brand Name

SelectAir

Version/Model Number

MDT24MEDRE-N

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)

-

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

5d93f7a6-9247-46ae-a4a2-9fc1b843ed2d

Public Version Date

June 28, 2019

Public Version Number

2

DI Record Publish Date

April 26, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MOXI ENTERPRISES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 91