AccessGUDID - DEVICE: Gossen Metrawatt SECULIFE (00863313000330)

GUDID

Device Identifier (DI) Information

Brand Name: Gossen Metrawatt SECULIFE
Version or Model: VL
Catalog Number: M695V
Company Name: BC GROUP INTERNATIONAL, INC.

Primary DI Number: 00863313000330
Issuing Agency: GS1
Device Count: 1

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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
External defibrillator tester	An electronic instrument used to test an external defibrillator to ensure compliance with performance specifications. The device connects to the output of the defibrillator, typically via contact plates, and measures the energy delivered by the defibrillator into a standard resistive load; it may also perform transcutaneous pacemaker testing, provide waveform information, and execute other quality control procedures. The device may be used to test the function of an external defibrillator periodically, after repair, or for training purposes.

GMDN Preferred Term Name

GMDN Definition

External defibrillator tester

An electronic instrument used to test an external defibrillator to ensure compliance with performance specifications. The device connects to the output of the defibrillator, typically via contact plates, and measures the energy delivered by the defibrillator into a standard resistive load; it may also perform transcutaneous pacemaker testing, provide waveform information, and execute other quality control procedures. The device may be used to test the function of an external defibrillator periodically, after repair, or for training purposes.

FDA Product Code

[?]

Product Code	Product Code Name
DRL	Tester, Defibrillator

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 24, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES

DEVICE: Gossen Metrawatt SECULIFE (00863313000330)