Mallinckrodt Manufacturing LLC

Address:1060 Allendale Dr,Port Allen,LA,70767,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

Set, Tubing And Support, Ventilator (W Harness) (BZO) (6) APPARATUS, NITRIC OXIDE, BACKUP DELIVERY (MRO) (4) ANALYZER, NITRIC OXIDE (MRP) (2) APPARATUS, NITRIC OXIDE DELIVERY (MRN) (2) Analyzer, nitrogen dioxide (MRQ) (2)

Premarket Exempt

No Yes

Clear

INOmax - 00810055283484 Catalog Number :

Device Description : LINE, PATIENT GAS SAMPLE, 10 FT/3 M WITH NAFION, BCG, CE

Device Class : 1

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

INOmax - 00810055283521 Catalog Number :

Device Description : TUBE, NO/N2 INJECTOR BCG, CE 2797

Device Class : 1

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

INOmax - 00810055284023 Catalog Number :

Device Description : FILTER ASSEMBLY, HYDROPHOBIC, CE

Device Class : 1

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

INOmax - 00810055284030 Catalog Number :

Device Description : LINE, PATIENT GAS SAMPLE & FILTER 10FT/3M BCG, CE

Device Class : 1

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : No

Device Count : 1

INOmax - 00810055284153 Catalog Number :

Device Description : Pack, Bunnell Life Pulse Disposable Adapters Convenience BCG, CE 2797

Device Class : 1

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

INOmax - 00810055284283 Catalog Number :

Device Description : LINE, MR PATIENT GAS SAMPLE & FILTER 16FT/5M BCG

Device Class : 1

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

INOmax DSIR Plus - 00867538000106 Catalog Number :

Device Description : INOmax DSIR Plus

Device Class : 2

Duns Number: 828331780

Premarket Exempt : No

Product Code : MRQ, MRO, MRP, MRN

Prescription Use : Yes

Device Count : 1

INOmax DSIR Plus MRI - 00867538000113 Catalog Number :

Device Description : INOmax DSIR Plus MRI

Device Class : 2

Duns Number: 828331780

Premarket Exempt : No

Product Code : MRO, MRQ, MRN, MRP

Prescription Use : Yes

Device Count : 1

INOblender - 00867538000120 Catalog Number :

Device Description : INOblender

Device Class : 2

Duns Number: 828331780

Premarket Exempt : No

Product Code : MRO

Prescription Use : Yes

Device Count : 1

INOblender MRI - 00867538000137 Catalog Number :

Device Description : INOblender MRI

Device Class : 2

Duns Number: 828331780

Premarket Exempt : No

Product Code : MRO

Prescription Use : Yes

Device Count : 1

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