Mallinckrodt Manufacturing LLC

Mallinckrodt Manufacturing LLC

Address:6603 Femrite Dr,MADISON,WI,53718,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) (8) Gas, Calibration (Specified Concentration) (BXK) (2)

Premarket Exempt

No Yes

Clear

INOcal - 00810055280025 Catalog Number : BOM-COM-0159

Device Description : INOcal 45 PPM NO Calibration Gas

Device Class : 1

Duns Number: 015322416

Premarket Exempt : Yes

Product Code : BXK

Prescription Use : Yes

Device Count : 1

INOcal - 00810055280056 Catalog Number : BOM-COM-0167

Device Description : INOcal 10 PPM NO2 Calibration Gas

Device Class : 1

Duns Number: 015322416

Premarket Exempt : Yes

Product Code : BXK

Prescription Use : Yes

Device Count : 1

INOmax - 00810055280254 Catalog Number :

Device Description : ADAPTER, 22F X 15M BCG

Device Class :

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

INOmax - 00810055280261 Catalog Number :

Device Description : ADAPTER, 22M/15F X 22M/15F BCG

Device Class : 1

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

INOmax - 00810055280278 Catalog Number :

Device Description : ADAPTER, GAS SAMPLE TEE BCG

Device Class :

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

INOmax - 00810055280285 Catalog Number :

Device Description : ADAPTER, 22 mm OD X 10 mm OD BCG, CE 2797

Device Class : 1

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

INOmax - 00810055280292 Catalog Number :

Device Description : ADAPTER, CUFF, 22mm ID X 22mm ID BCG, CE 2797

Device Class : 1

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

INOmax - 00810055280889 Catalog Number :

Device Description : ADAPTER, CUFF, 22mm ID X 22mm ID BCG, CE 2797

Device Class : 1

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

INOmax - 00810055283446 Catalog Number :

Device Description : Adapter, 22M/15F X 22M/15F BCG, CE 2797

Device Class : 1

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

INOmax - 00810055283477 Catalog Number :

Device Description : TEE, O2 TUBING SAMPLE BCG, CE 2797

Device Class : 1

Duns Number: 828331780

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

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