GRI-FILL 2 Ways Set

GUDID 08426314575768

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 different multi-ingredient solutions and to channel them into a final suitable IV container. The set is a disposable component of the compounding device. Gri-fill 2 Ways Set is made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Set is available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the Gri-fill 2 Ways Set.

LABORATORIOS GRIFOLS SA

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• Primary Device ID: 08426314575768
• NIH Device Record Key: 6bd3664a-6786-46c0-b5ae-2e391238bdaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRI-FILL 2 Ways Set
• Version Model Number: GRI-FILL 2 Ways Set
• 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	08426314575768 [Primary]
GS1	28426314575762 [Package]; Package: Box [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050339

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: 2022-03-23
• Device Publish Date: 2022-03-15

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: 2022-03-23Gri-fill 2 Ways Set is a fluid transfer set for use with the Gri-fill pharmacy compounding device in order to compound or mix different multi-ingredient solutions and to channel them into a final suitable IV container. The set is a disposable component of the compounding device. Gri-fill 2 Ways Set is made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Set is available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the Gri-fill 2 Ways Set.
• 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: 2021-11-02 Fluid transfer set consisting of PVC tubing linking 6 mini-spikes to be used in conjunction with 2 ways transfer set through whi