AccessGUDID - DEVICE: VIDAS® 3 SAMPLE TIPS (03573026615277)

GUDID

Device Identifier (DI) Information

Brand Name: VIDAS® 3 SAMPLE TIPS
Version or Model: VIDAS® 3 SAMPLE TIPS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX SA

Primary DI Number: 03573026615277
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 48
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: This single-use tips are used by the VIDAS®3 pipetting unit to pipette the samples according to the defined loading plan.

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?
63337	Pipette tip IVD	A device formed as a pointed cylindrical tip that is attached to the dispensing opening of a pipette, or a dispenser, and where the required volume of liquid (e.g., reagent, buffer, biological specimen) is drawn for delivery to a target receptacle during an in vitro diagnostic procedure. It is typically used for manual procedures or onboard automated liquid handling instruments or analysers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: 4d58fe99-4fd0-48eb-8851-ef8747e86074
Public Version Date: September 26, 2022
Public Version Number: 3
DI Record Publish Date: July 24, 2020