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 electrode sleeve- sm - 00857771003439 Catalog Number : GAR100

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

conductive electrode sleeve, med. - 00857771003446 Catalog Number : GAR101

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Conductive Electrode Sleeve - large - 00857771003453 Catalog Number : GAR102

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Conductive electrode garment sleeve XL - 00857771003460 Catalog Number : GAR103

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Conductive eletrode sleeve XXL - 00857771003477 Catalog Number : GAR104

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Conductive fabric sock- sm. - 00857771003484 Catalog Number : GAR120

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Conductive fabric sock- med. - 00857771003491 Catalog Number : GAR121

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Conductive fabric sock- lg. - 00857771003507 Catalog Number : GAR122

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Conductive fabric sock- XL - 00857771003514 Catalog Number : GAR123

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

full back conductive garment vest- med. - 00857771003521 Catalog Number : KV1003823

Device Description : with (8) 2x3 eletrodes

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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