Gossen Metrawatt SECULIFE - Defibrillator Analyzer Variable Load, for use - BC GROUP INTERNATIONAL, INC.

Duns Number:602930208

Device Description: Defibrillator Analyzer Variable Load, for use with Seculife DF Base and Seculife DF+ - pri Defibrillator Analyzer Variable Load, for use with Seculife DF Base and Seculife DF+ - private labeled for Gossen Metrawatt

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More Product Details

Catalog Number

M695V

Brand Name

Gossen Metrawatt SECULIFE

Version/Model Number

VL

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153210

Product Code Details

Product Code

DRL

Product Code Name

Tester, Defibrillator

Device Record Status

Public Device Record Key

4e01348a-c5a3-4a39-8488-8aeb795a3105

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BC GROUP INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6