BAXALTA US INC.

Address:1200 Lakeside Drive,Bannockburn,IL,60015,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, Administration, Intravascular (FPA) (3) Set, I.V. Fluid Transfer (LHI) (2)

Premarket Exempt

Clear

BAXJECT II NTD - 00642621003949 Catalog Number : 1505834

Device Class : 2

Duns Number: 079887619

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

FlowEase [Subcutaneous] Infusion Set - 00642621029239 Catalog Number : 1M2006

Device Class : 2

Duns Number: 079887619

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FlowEase [Subcutaneous] Infusion Set - 00642621029246 Catalog Number : 1M2009

Device Class : 2

Duns Number: 079887619

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FlowEase [Subcutaneous] Infusion Set - 00642621029253 Catalog Number : 1M2012

Device Class : 2

Duns Number: 079887619

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

BAXJECT II Hi-Flow NTD - 00642621029383 Catalog Number : 340601

Device Class : 2

Duns Number: 079887619

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

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