AccessGUDID - DEVICE: Selectra (03661540600401)

GUDID

Device Identifier (DI) Information

Brand Name: Selectra
Version or Model: ProM
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6003-436
Company Name: ELITechGroup B.V.

Primary DI Number: 03661540600401
Issuing Agency: GS1
Commercial Distribution End Date: December 23, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 415733737 *Terms of Use

Device Description: No description.

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?
56679	Multiple clinical chemistry analyser IVD, laboratory, semi-automated	An electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or multiple technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JGS	Electrode, Ion Specific, Sodium

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102647	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: 906b3853-65d5-4ead-9016-9267fde4c7cc
Public Version Date: December 29, 2021
Public Version Number: 5
DI Record Publish Date: November 18, 2016