Catalog Number

-

Brand Name

AirPal Repositioning Sheet

Version/Model Number

RM-AP-050SPS

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

FMR

Product Code Name

Device, Transfer, Patient, Manual

Public Device Record Key

4956bde0-2d5c-4e49-a88e-6de1f590996f

Public Version Date

October 19, 2021

Public Version Number

2

DI Record Publish Date

February 24, 2021

Package DI Number

10816317023895

Quantity per Package

5

Contains DI Package

00816317023898

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case