QUICKPIN

GUDID 38426314734562

QUICKPIN is a luer-lock spike used in manual or automated pharmacy compounding for addition and/or extraction of IV substances from rubber stoppered containers including multi-dose vials.

LABORATORIOS GRIFOLS SA

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• Primary Device ID: 38426314734562
• NIH Device Record Key: a5eae159-7c74-4c7f-8e48-842212c49665
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUICKPIN
• Version Model Number: QUICKPIN
• Company DUNS: 463719725
• 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	08426314734561 [Primary]
GS1	28426314734565 [Package]; Contains: 08426314734561; Package: box [50 Units]; In Commercial Distribution
GS1	38426314734562 [Package]; Contains: 28426314734565; Package: Box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082752

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: 5
• Public Version Date: 2023-07-20
• Device Publish Date: 2017-04-05

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: 2023-07-20QUICKPIN is a luer-lock spike used in manual or automated pharmacy compounding for addition and/or extraction of IV substances from rubber stoppered containers including multi-dose vials.
• 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: 2021-11-02 Fluid transfer set consisting of PVC tubing linking 6 mini-spikes to be used in conjunction with 2 ways transfer set through whi