LUMITEX, INC.

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- Catalog Number : B 61100

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

- Catalog Number : B 61101

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

- Catalog Number : 012139

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in a hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.

Device Class : 2

Duns Number: 108631797

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in a hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.

Device Class : 2

Duns Number: 108631797

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in a hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.

Device Class : 2

Duns Number: 108631797

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1