AccessGUDID - DEVICE: MISSION U500 URINE ANALYZER (20682607200515)

GUDID

Device Identifier (DI) Information

Brand Name: MISSION U500 URINE ANALYZER
Version or Model: U211-111
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U211-111
Company Name: Acon Laboratories, Inc.

Primary DI Number: 20682607200515
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 781100966 *Terms of Use

Device Description: URINE ANALYZER with Barcode Reader

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:	Yes
Combination Product:	Yes
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?
57861	Urine analyser IVD, point-of-care	A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQO	AUTOMATED URINALYSIS SYSTEM

FDA Premarket Submission

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

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
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: df388dd4-ec5c-4013-ba2e-4b3a00d5b03b
Public Version Date: June 20, 2025
Public Version Number: 3
DI Record Publish Date: March 08, 2024