AccessGUDID - DEVICE: Mix2Vial Transfer Device (07290108240429)

GUDID

Device Identifier (DI) Information

Brand Name: Mix2Vial Transfer Device
Version or Model: 8074022
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDIMOP MEDICAL PROJECTS LTD.

Primary DI Number: 07290108240429
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600267793 *Terms of Use

Device Description: Mix2Vial 20/20mm W/20mic large filter TG S-Spike

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Medication transfer needle, filtering	A sterile, slender, sharply-pointed metal tube typically intended to be used in the pharmacy to transfer medication from a vial to another container. It includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient-administered medication. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Medication transfer needle, filtering

A sterile, slender, sharply-pointed metal tube typically intended to be used in the pharmacy to transfer medication from a vial to another container. It includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient-administered medication. This is a single-use device.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031861	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 07f79932-65c2-40d3-93d0-fd286bd6a88f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 01, 2016