FLEBOSET

GUDID 28426314583521

FLEBOSET MULTIPLE is a fluid transfer tubing set used to enable continuous (uninterrupted) delivery of drug solutions from 6 glass source containers. It is used in pharmacy compounding or for IV fluid transfer to minimize manipulation when working with small volumen source containers. The device is made up of 6 spikes connected in series with flexible tubing segments, each segment with an idividual clamp. The set terminal, for connection to the pharmacy compounding device sets or administration sets (gravity or pump) consists of a spikeable twist-off valve connector.

LABORATORIOS GRIFOLS SA

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• Primary Device ID: 28426314583521
• NIH Device Record Key: 177558a4-5972-4fcf-a98b-85a7cc930748
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEBOSET
• Version Model Number: MULTIPLE
• 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	08426314583527 [Primary]
GS1	28426314583521 [Package]; Contains: 08426314583527; Package: box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040456

FDA Product Code

• 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