Catalog Number

7871800000

Brand Name

SENSIMEDICAL Sterile Water for Inhalation, USP

Version/Model Number

7871800000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K881184,K881184

Product Code

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

dbd501f8-51a0-4cd1-8a97-107c09786355

Public Version Date

July 01, 2022

Public Version Number

1

DI Record Publish Date

June 23, 2022

Package DI Number

00810083350264

Quantity per Package

14

Contains DI Package

00810083350271

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-