BIOMEDICAL LIFE SYSTEMS, INC.

Address:1954 Kellogg Avenue,Carlsbad,CA,92008,US

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Filters

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

Electrode, Cutaneous (GXY) (10)

Premarket Exempt

Clear

Conductive garment electrode glove sm - 00850706007007 Catalog Number : GAR110

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Conductive garment electrode glove med. - 00850706007014 Catalog Number : GAR111

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Conductive garment electrode glove lg. - 00850706007021 Catalog Number : GAR112

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Univ Full Back w (8) 2x3 electrodes - 00850706007038 Catalog Number : KV1016823

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Butterfly Pre Wired Electrodes - 00850706007120 Catalog Number : EBTF400600M

Device Description : butterfly 4" x 6"- 2 per pack

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Butterfly Pre-wired electrodes - 00850706007137 Catalog Number : EBTF400600M

Device Description : butterfly electrodes 10 packs of 2 ea = 1 bag (bx)

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

BioStim pre wired electodes - 00850706007144 Catalog Number : EERC200MW

Device Description : 12 total electrodes - 3 pk of 4 ea

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioStim Pre Wired Oval Electrodes - 00850706007168 Catalog Number :

Device Description : 3 pk of 4- 2" x 4" oval pigtail pre wired electrodes

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioStim Pre Wired Butterfly Electrodes - 00850706007175 Catalog Number : EBTF400600MW

Device Description : Pack of three ea EBTF400600 containing two 4" x 6" electrodes. TOTAL 6.

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioStim Pre Wired Round Electrodes - 00850706007199 Catalog Number : EERD200MW

Device Description : 12 ea = 3 EERD200M - 1 EERD200MW

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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