Catalog Number

-

Brand Name

Ambu

Version/Model Number

74825-60/12

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

-

Product Code

GXZ

Product Code Name

Electrode, Needle

Public Device Record Key

bf0fbb54-179f-4a32-90f3-f75810c6961c

Public Version Date

July 12, 2022

Public Version Number

1

DI Record Publish Date

July 04, 2022

Package DI Number

08718375869291

Quantity per Package

12

Contains DI Package

08718375869277

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfbox