BC Biomedical Defibrillator Analyzer Variable Load DA-2006-VL

GUDID 00863313000323

Defibrillator Analyzer Variable Load, for use with DA-2006 and DA-2006P models.

BC GROUP INTERNATIONAL, INC.

External defibrillator tester

• Primary Device ID: 00863313000323
• NIH Device Record Key: e5a854db-0678-479c-8ab7-dd3c9eb8f770
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BC Biomedical Defibrillator Analyzer Variable Load
• Version Model Number: DA-2006-VL
• Catalog Number: DA-2006-VL
• Company DUNS: 602930208
• Company Name: BC GROUP INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863313000323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153210

FDA Product Code

• DRL: Tester, Defibrillator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by BC GROUP INTERNATIONAL, INC.

• 00863313000309 - BC Biomedical Defibrillator Analyzer: 2018-07-06 Defibrillator Analyzer, without Transcutaneous Pacemaker Input
• 00863313000316 - BC Biomedical Defibrillator Analyzer: 2018-07-06 Defibrillator Analyzer, with Transcutaneous Pacemaker Input
• 00863313000323 - BC Biomedical Defibrillator Analyzer Variable Load: 2018-07-06Defibrillator Analyzer Variable Load, for use with DA-2006 and DA-2006P models.
• 00863313000323 - BC Biomedical Defibrillator Analyzer Variable Load: 2018-07-06 Defibrillator Analyzer Variable Load, for use with DA-2006 and DA-2006P models.
• 00863313000330 - Gossen Metrawatt SECULIFE: 2018-07-06 Defibrillator Analyzer Variable Load, for use with Seculife DF Base and Seculife DF+ - private labeled for Gossen Metrawatt
• 00863313000347 - Gossen Metrawatt SECULIFE: 2018-07-06 Defibrillator Analyzer, with Transcutaneous Pacemaker Input - private labeled for Gossen Metrawatt
• 00863313000354 - Gossen Metrawatt SECULIFE: 2018-07-06 Defibrillator Analyzer, without Transcutaneous Pacemaker Input - private labeled for Gossen Metrawatt