Catalog Number

AS36094

Brand Name

ALPHA SOURCE BATTERY

Version/Model Number

AS36094

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

-

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

K922909

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

74981c0e-669b-4e3e-ae96-5e0c91402eff

Public Version Date

June 28, 2019

Public Version Number

1

DI Record Publish Date

June 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-