410 MEDICAL INNOVATION, LLC

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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) (4)

Premarket Exempt

Clear

LifeFlow Rapid Infusion System - 00860000288606 Catalog Number : FG5001

Device Description : Rapid IV infusion system including handle with sterile tubing set SA5110

Device Class : 2

Duns Number: 050212206

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

LifeFlow Blood Infuser - 00860000288637 Catalog Number : FG5005

Device Description : FG5005 consists of 1 LifeFlow handle, 1 LifeFlow Blood Tubing set, and associate FG5005 consists of 1 LifeFlow handle, 1 LifeFlow Blood Tubing set, and associated labeling.

Device Class : 2

Duns Number: 050212206

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

LifeFlow Replacement Blood Tubing Sets - 00860000288644 Catalog Number : FG5006

Device Description : FG5006 consists of 1 LifeFlow Blood Tubing set and associated labelling. FG5006 FG5006 consists of 1 LifeFlow Blood Tubing set and associated labelling. FG5006 is used in conjunction with FG5005.

Device Class : 2

Duns Number: 050212206

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

LifeFlow Rapid Infusion System - B355FG50011 Catalog Number : FG5001

Device Description : Rapid Infusion system including handle and sterile tubing set SA5101

Device Class : 2

Duns Number: 050212206

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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