Catalog Number

-

Brand Name

AirStrip ONE Web Client

Version/Model Number

2003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160862

Product Code

MSX

Product Code Name

System, Network And Communication, Physiological Monitors

Public Device Record Key

72ead20e-1bcc-4b0b-838a-c0b0b2ecf01c

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

September 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-