FDA.reportPublic FDA data

FLEBOSET

Primary DI
28426314792572
Brand
FLEBOSET
Company
LABORATORIOS GRIFOLS SA
Model
DOUBLE
Device description
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.
Published
2017-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPKTubing, Fluid Delivery
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPKTubing, Fluid DeliveryGeneral Hospital2
LHISet, I.V. Fluid TransferGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102590000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102590000FLEBOSET DOUBLELaboratorios Grifols, S.A.2011-01-13LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28426314792572PackageGS135In Commercial Distribution
08426314792578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2842631479257228426314792572
08426314792578084263147925788426314792578

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
463720681
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08426314391399GRI-BAG1002021-10-26
08426314391412GRI-BAG2502021-10-26
08426314391474GRI-BAG5002021-10-26
08426314391481GRI-BAG10002021-10-26
08426314778770GRI-FILL 6 to1 Set-2021-10-25
08426314387972GRI-FILL PERISTALTIC SET-2018-11-21
08426314948258GRI-FILL-2023-07-19
08426314575768GRI-FILL 2 Ways SetGRI-FILL 2 Ways Set2022-03-15
08426314601146SET GRI-FILL 3.02 ways2017-01-02
08426314734561QUICKPINQUICKPIN2017-04-05
08426314792578FLEBOSETDOUBLE2017-04-05
38426314734562QUICKPINQUICKPIN2017-04-05
28426314391393GRI-BAG1002021-10-26
28426314391416GRI-BAG2502021-10-26
28426314391478GRI-BAG5002021-10-26
28426314391485GRI-BAG10002021-10-26
28426314778774GRI-FILL 6 to1 Set-2021-10-25
08426314546836GRI-BAG1002017-01-02
08426314604031GRI-BAG2502017-04-05
08426314575683GRI-BAG10002017-04-05

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10815879021295IV PlusNEXUS MEDICAL, LLCLHI2021-01-20
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