BC GROUP INTERNATIONAL, INC.

Address:3081 Elm Point Industrial Dr,Saint Charles,MO,63301,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tester, Defibrillator (DRL) (6)

Premarket Exempt

Clear

BC Biomedical Defibrillator Analyzer - 00863313000309 Catalog Number : DA-2006

Device Description : Defibrillator Analyzer, without Transcutaneous Pacemaker Input

Device Class : 2

Duns Number: 602930208

Premarket Exempt : No

Product Code : DRL

Prescription Use : No

Device Count : 1

BC Biomedical Defibrillator Analyzer - 00863313000316 Catalog Number : DA-2006P

Device Description : Defibrillator Analyzer, with Transcutaneous Pacemaker Input

Device Class : 2

Duns Number: 602930208

Premarket Exempt : No

Product Code : DRL

Prescription Use : No

Device Count : 1

BC Biomedical Defibrillator Analyzer Variable Load - 00863313000323 Catalog Number : DA-2006-VL

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

Device Class : 2

Duns Number: 602930208

Premarket Exempt : No

Product Code : DRL

Prescription Use : No

Device Count : 1

Gossen Metrawatt SECULIFE - 00863313000330 Catalog Number : M695V

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

Device Class : 2

Duns Number: 602930208

Premarket Exempt : No

Product Code : DRL

Prescription Use : No

Device Count : 1

Gossen Metrawatt SECULIFE - 00863313000347 Catalog Number : M695P

Device Description : Defibrillator Analyzer, with Transcutaneous Pacemaker Input - private labeled fo Defibrillator Analyzer, with Transcutaneous Pacemaker Input - private labeled for Gossen Metrawatt

Device Class : 2

Duns Number: 602930208

Premarket Exempt : No

Product Code : DRL

Prescription Use : No

Device Count : 1

Gossen Metrawatt SECULIFE - 00863313000354 Catalog Number : M695Q

Device Description : Defibrillator Analyzer, without Transcutaneous Pacemaker Input - private labeled Defibrillator Analyzer, without Transcutaneous Pacemaker Input - private labeled for Gossen Metrawatt

Device Class : 2

Duns Number: 602930208

Premarket Exempt : No

Product Code : DRL

Prescription Use : No

Device Count : 1

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