Catalog Number

-

Brand Name

Ambu

Version/Model Number

75021-150/25

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

512f9c43-f428-4c7c-8fc1-458937610beb

Public Version Date

July 12, 2022

Public Version Number

1

DI Record Publish Date

July 04, 2022

Package DI Number

08718375869178

Quantity per Package

25

Contains DI Package

08718375869154

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfbox