GRI-FILL 6 to1 Set

GUDID 28426314778774

Fluid transfer set consisting of PVC tubing linking 6 mini-spikes to be used in conjunction with 2 ways transfer set through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the source substances. The spike on each line facilitates easy puncture of thick rubber stoppers of small diameter. The device provides fast fluid addition and extraction due to the large surface area of the air-filter that quickly equalizes pressures.

LABORATORIOS GRIFOLS SA

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• Primary Device ID: 28426314778774
• NIH Device Record Key: 88b00d8a-25e1-49bb-9da3-61a084f51a13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRI-FILL 6 to1 Set
• Version Model Number: -
• 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	08426314778770 [Primary]
GS1	28426314778774 [Package]; Contains: 08426314778770; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093182

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-02
• Device Publish Date: 2021-10-25

Devices Manufactured by LABORATORIOS GRIFOLS SA

• 08426314948258 - GRI-FILL: 2023-07-27 GRI-FILL is a pharmacy compounding device (PCD) and as such is an electromechanical device controlled by software intended to de
• 38426314734562 - QUICKPIN: 2023-07-20 QUICKPIN is a luer-lock spike used in manual or automated pharmacy compounding for addition and/or extraction of IV substances f
• 08426314575768 - GRI-FILL 2 Ways Set: 2022-03-23 Gri-fill 2 Ways Set is a fluid transfer set for use with the Gri-fill pharmacy compounding device in order to compound or mix di
• 28426314391393 - GRI-BAG: 2021-11-03 GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sea
• 28426314391416 - GRI-BAG: 2021-11-03 GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sea
• 28426314391478 - GRI-BAG: 2021-11-03 GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sea
• 28426314391485 - GRI-BAG: 2021-11-03 GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sea
• 28426314778774 - GRI-FILL 6 to1 Set: 2021-11-02Fluid transfer set consisting of PVC tubing linking 6 mini-spikes to be used in conjunction with 2 ways transfer set through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the source substances. The spike on each line facilitates easy puncture of thick rubber stoppers of small diameter. The device provides fast fluid addition and extraction due to the large surface area of the air-filter that quickly equalizes pressures.
• 28426314778774 - GRI-FILL 6 to1 Set: 2021-11-02 Fluid transfer set consisting of PVC tubing linking 6 mini-spikes to be used in conjunction with 2 ways transfer set through whi