Catalog Number

PRT-00980-000

Brand Name

VOCSN Removable, Rechargeable Battery Set

Version/Model Number

Lithium-ion

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162877,K162877

Product Code

CAW

Product Code Name

Generator, Oxygen, Portable

Public Device Record Key

5797734a-045d-43e3-a98c-ad1633dfb164

Public Version Date

April 20, 2020

Public Version Number

3

DI Record Publish Date

October 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-