AccessGUDID - DEVICE: FlexLab (07640172340004)

GUDID

Device Identifier (DI) Information

Brand Name: FlexLab
Version or Model: FLX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Inpeco SA

Primary DI Number: 07640172340004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 484880690 *Terms of Use

Device Description: The FlexLab Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates multiple Analytical instruments into a unified workstation.

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:	No
Prescription Use (Rx):	No
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?
57871	Specimen processing instrument IVD	An electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEM	Electrode, Ion Specific, Potassium

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121012	000

Device Exempt from Premarket Submission: No 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: 0db7ccee-b2bd-498f-9d67-15e52943bb12
Public Version Date: October 14, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2016