AccessGUDID - DEVICE: SET GRI-FILL 3.0 (08426314601146)

GUDID

Device Identifier (DI) Information

Brand Name: SET GRI-FILL 3.0
Version or Model: 2 ways
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: LABORATORIOS GRIFOLS SA

Primary DI Number: 08426314601146
Issuing Agency: GS1
Commercial Distribution End Date: January 05, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 463720681 *Terms of Use

Device Description: SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 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. The 1 WAY / 2 WAY models are made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Sets are available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the 1 or 2 way transfer sets. The MULTIPLE model is also used as an accessory with the 1IWAY I 2WAY sets for channeling the same solution from up to six (6) source containers delivering them into a final IV container. It is made up of connectors and tubing to enable interconnection of the different source containers.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43324	Fluid transfer set, general-purpose	A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHI	Set, I.V. Fluid Transfer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050339	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 75021617-fcfb-4c07-8bfc-9988e686d653
Public Version Date: January 08, 2024
Public Version Number: 9
DI Record Publish Date: January 02, 2017