Catalog Number

-

Brand Name

AIR-MATT

Version/Model Number

AM50DE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

FMR

Product Code Name

Device, Transfer, Patient, Manual

Public Device Record Key

81e35679-2327-4cba-9216-0878c096d34c

Public Version Date

September 20, 2018

Public Version Number

1

DI Record Publish Date

August 20, 2018

Package DI Number

20854564008200

Quantity per Package

2

Contains DI Package

10854564008203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case (2 boxes)