ALPHA SOURCE BATTERY - 12V 28AH SLA BATTERY - ALPHA SOURCE INC.

Duns Number:154199392

Device Description: 12V 28AH SLA BATTERY

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More Product Details

Catalog Number

AS35092

Brand Name

ALPHA SOURCE BATTERY

Version/Model Number

AS35092

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

FQO

Product Code Name

Table, Operating-Room, Ac-Powered

Device Record Status

Public Device Record Key

b0e35a07-b0d8-4c11-8013-e98ce43f7b8a

Public Version Date

July 10, 2019

Public Version Number

1

DI Record Publish Date

July 02, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALPHA SOURCE INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 37
3 A medical device with high risk that requires premarket approval 26