3.6V Battery - Description: The battery is an accessory for - SOOIL DEVELOPMENT CO.,LTD

Duns Number:688006266

Device Description: Description: The battery is an accessory for insulin pump use. it is the main power of DAN

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

3.6V Battery

Version/Model Number

Bobbin

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K063126,K063126

Product Code Details

Product Code

LGZ

Product Code Name

Warmer, Thermal, Infusion Fluid

Device Record Status

Public Device Record Key

7079739f-0f6c-44ed-b857-f9d7bc484ec1

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

08809220581021

Quantity per Package

8

Contains DI Package

08809220581014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"SOOIL DEVELOPMENT CO.,LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5