Catalog Number

-

Brand Name

AIRPAL

Version/Model Number

N034SPS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

FRZ

Product Code Name

Device, Patient Transfer, Powered

Public Device Record Key

7baf21d1-7d57-4f98-a36b-a28c72274d25

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2017

Package DI Number

74717677480763

Quantity per Package

10

Contains DI Package

04717677480764

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-