Catalog Number

-

Brand Name

ResQGARD Military Kit

Version/Model Number

12-0706-000

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K033401

Product Code

BWF

Product Code Name

SPIROMETER, THERAPEUTIC (INCENTIVE)

Public Device Record Key

3adc6955-ac95-434e-a5f5-e006928acadf

Public Version Date

March 24, 2022

Public Version Number

2

DI Record Publish Date

June 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-