LABORATORIOS GRIFOLS SA

Address:POL. LEVANTE C/CAN GUASCH, 2,PARETS DEL VALLES Barcelona,ES

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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

Set, I.V. Fluid Transfer (LHI) (1)

Premarket Exempt

Clear

FLEBOSET - 08426314792578 Catalog Number :

Device Description : FLEBOSET DOUBLE is a disposable transfer set through which substances form 2 dif FLEBOSET DOUBLE is a disposable transfer set through which substances form 2 different vials containing the same solution may be continuously delivered for: a) IV administration when used in conjunction with a gravity or pump infusion set, with luer-lock connection to the drip chamber, to cannel the solution from the source vials to the infusion set, and b) Pharmacy compounding when used in conjuntion with the Grifill pharmacy compounding device and associated transfers sets. Equipped with a spike on each line and a 0.2um hydrophobic air-filter, it minimizes teh formation of aerosols when preparing/dispensing the source substances.

Device Class : 2

Duns Number: 463720681

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

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