AccessGUDID - DEVICE: Uricult® CLED/MacConkey (06438115000020)

GUDID

Device Identifier (DI) Information

Brand Name: Uricult® CLED/MacConkey
Version or Model: 68019
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1001
Company Name: Aidian Oy

Primary DI Number: 06438115000020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 401656868 *Terms of Use

Device Description: A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.

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:	Yes
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?
62106	Multiple formulation agar culture medium IVD	A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSH	Culture Media, Non-Selective And Differential

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
Storage Environment Temperature: between 45 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 7 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f089692e-2ba5-48e5-8933-8aa045d9a9fe
Public Version Date: March 02, 2020
Public Version Number: 5
DI Record Publish Date: May 13, 2016