AccessGUDID - DEVICE: Bio30+ System Physio Accel (05056336800192)

GUDID

Device Identifier (DI) Information

Brand Name: Bio30+ System Physio Accel
Version or Model: 80-6000-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOCHROM LIMITED

Primary DI Number: 05056336800192
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 235280646 *Terms of Use

Device Description: Ion exchange chromatography analyzer with lithium accelerated column, LED monitor, computer, autosampler and Openlab software

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?
57801	Amino acid analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of individual amino acids in a protein sample obtained from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical 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: 115dc653-b2a8-448a-8db5-33b8b3069205
Public Version Date: July 24, 2023
Public Version Number: 1
DI Record Publish Date: July 14, 2023