BC Biomedical Defibrillator Analyzer DA-2006P

GUDID 00863313000316

Defibrillator Analyzer, with Transcutaneous Pacemaker Input

BC GROUP INTERNATIONAL, INC.

External defibrillator tester

• Primary Device ID: 00863313000316
• NIH Device Record Key: cfe5339b-bf37-469c-a9a0-1cb85b4400ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BC Biomedical Defibrillator Analyzer
• Version Model Number: DA-2006P
• Catalog Number: DA-2006P
• 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

Customer Support Contacts

• Phone: (314) 638-3800
• Email: sales@bcgroupintl.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863313000316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110192

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

On-Brand Devices [BC Biomedical Defibrillator Analyzer]

• 00863313000316: Defibrillator Analyzer, with Transcutaneous Pacemaker Input
• 00863313000309: Defibrillator Analyzer, without Transcutaneous Pacemaker Input