NOXBOX LTD

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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

Analyzer, Gas, Oxygen, Gaseous-Phase (CCL) (10) Analyzer, Nitric Oxide (MRP) (10) Analyzer, Nitrogen Dioxide (MRQ) (10) Apparatus, Nitric Oxide Delivery (MRN) (10) Apparatus, Nitric Oxide, Backup Delivery (MRO) (10)

Premarket Exempt

Clear

NOxBOXi - 05060541640016 Catalog Number : NXBNOXBOX-I

Device Description : Nitric Oxide Delivery and Monitoring System - Head Unit Only

Device Class :

Duns Number: 220841986

Premarket Exempt : No

Product Code : CCL, MRO, MRQ, MRP, MRN

Prescription Use : Yes

Device Count : 1

NOxBOXi - 05060541640023 Catalog Number : NXBNOXDC-I

Device Description : Nitric Oxide Delivery and Monitoring System - Head unit and Trolley

Device Class : 2

Duns Number: 220841986

Premarket Exempt : No

Product Code : CCL, MRO, MRQ, MRP, MRN

Prescription Use : Yes

Device Count : 1

NOxBOXi - 05060541640030 Catalog Number : NXBNOXKIT-2-22

Device Description : Single use 22mm size 2 delivery and sampling kit

Device Class : 2

Duns Number: 220841986

Premarket Exempt : No

Product Code : CCL, MRO, MRQ, MRP, MRN

Prescription Use : Yes

Device Count : 1

NOxBOXi - 05060541640047 Catalog Number : NXBNOXKIT-2-15

Device Description : Single use 15mm size 2 delivery and sampling kit

Device Class : 2

Duns Number: 220841986

Premarket Exempt : No

Product Code : CCL, MRQ, MRP, MRO, MRN

Prescription Use : Yes

Device Count : 1

NOxBOXi - 05060541640054 Catalog Number : NXBNOXKIT-1-10

Device Description : Single use 10mm delivery and sampling kit

Device Class : 2

Duns Number: 220841986

Premarket Exempt : No

Product Code : CCL, MRQ, MRP, MRO, MRN

Prescription Use : Yes

Device Count : 1

NOxBOXi - 05060541640061 Catalog Number : NXBNOXKIT-2-12

Device Description : Single use 12mm size 2 delivery and sampling kit

Device Class : 2

Duns Number: 220841986

Premarket Exempt : No

Product Code : CCL, MRQ, MRP, MRO, MRN

Prescription Use : Yes

Device Count : 1

NOxBOXi - 05060541640078 Catalog Number : NXBNOXBOXI-TEST

Device Description : System Test kit

Device Class :

Duns Number: 220841986

Premarket Exempt : No

Product Code : CCL, MRQ, MRP, MRO, MRN

Prescription Use : Yes

Device Count : 1

NOxBOXi - 05060541640085 Catalog Number : NXBNOXKIT-HFJV

Device Description : Single use connections kit for Bunnell Jet ventilator

Device Class : 2

Duns Number: 220841986

Premarket Exempt : No

Product Code : CCL, MRQ, MRP, MRO, MRN

Prescription Use : Yes

Device Count : 1

NOxBOXi - 05060541640184 Catalog Number : NXB034-18-00520-V

Device Description : Calibration gas NO

Device Class : 2

Duns Number: 220841986

Premarket Exempt : No

Product Code : CCL, MRQ, MRP, MRO, MRN

Prescription Use : Yes

Device Count : 1

NOxBOXi - 05060541640191 Catalog Number : NXB034-20-01010-V

Device Description : Calibration Gas NO2

Device Class : 2

Duns Number: 220841986

Premarket Exempt : No

Product Code : CCL, MRQ, MRP, MRO, MRN

Prescription Use : Yes

Device Count : 1

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