Catalog Number

60708

Brand Name

AcuCare

Version/Model Number

F1-0

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"

Yes

For Single-Use

-

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

-

Product Code

BSJ

Product Code Name

Mask, Gas, Anesthetic

Public Device Record Key

92860914-c656-4fce-b617-4ffa9780cf22

Public Version Date

July 23, 2021

Public Version Number

3

DI Record Publish Date

February 27, 2018

Package DI Number

00619498002726

Quantity per Package

20

Contains DI Package

00619498607082

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-