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

Fluid transfer set, general-purpose

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

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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