AccessGUDID - DEVICE: CARDINAL HEALTH (10885380151903)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: CHUA115
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CHUA115
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885380151903
Issuing Agency: GS1
Commercial Distribution End Date: August 10, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: UA Control Tube Normal -90mL

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):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
30219	Multiple urine analyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJW	Urinalysis controls (assayed and unassayed)

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 15 Milliliter

Device Record Status

Public Device Record Key: 622ccadc-17bb-4237-960d-dcfdeae3813f
Public Version Date: August 10, 2020
Public Version Number: 3
DI Record Publish Date: May 16, 2019