FLEBOSET

GUDID 28426314792572

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.

LABORATORIOS GRIFOLS SA

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• Primary Device ID: 28426314792572
• NIH Device Record Key: d6fb350b-b710-4102-b16e-931b20b60c3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEBOSET
• Version Model Number: DOUBLE
• Company DUNS: 463720681
• Company Name: LABORATORIOS GRIFOLS SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426314792578 [Primary]
GS1	28426314792572 [Package]; Contains: 08426314792578; Package: Box [35 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102590

FDA Product Code

• FPK: Tubing, Fluid Delivery
• LHI: Set, I.V. Fluid Transfer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-19
• Device Publish Date: 2017-04-05

On-Brand Devices [FLEBOSET]

• 28426314792572: FLEBOSET DOUBLE is a disposable transfer set through which substances form 2 different vials con
• 28426314583521: FLEBOSET MULTIPLE is a fluid transfer tubing set used to enable continuous (uninterrupted) deliv