AccessGUDID - DEVICE: IRISpec (10837461001973)

GUDID

Device Identifier (DI) Information

Brand Name: IRISpec
Version or Model: CA/CB Twinset
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 800-7211
Company Name: IRIS INTERNATIONAL, INC.

Primary DI Number: 10837461001973
Issuing Agency: GS1
Commercial Distribution End Date: December 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 098240690 *Terms of Use

Device Description: IRISpec CA/CB Twinset

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?
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 68df8eac-5d16-4657-b807-6460c81e0088
Public Version Date: September 08, 2023
Public Version Number: 4
DI Record Publish Date: September 07, 2016