Catalog Number

-

Brand Name

Foot Strap

Version/Model Number

SOW005

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

K081485

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

82b7a599-a1c4-4f90-9856-906c41b35251

Public Version Date

July 04, 2022

Public Version Number

5

DI Record Publish Date

April 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-