AccessGUDID - DEVICE: IRISpec (10837461002680)

GUDID

Device Identifier (DI) Information

Brand Name: IRISpec
Version or Model: CA/CB/CC URINE CHEMSITRY CONTROLS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800-7702
Company Name: BECKMAN COULTER IRELAND INC.

Primary DI Number: 10837461002680
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985071975 *Terms of Use

Device Description: IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS

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 [?]
K072640	000

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: 421b7ef5-844f-4ab7-a747-ef6caa42d2e9
Public Version Date: October 13, 2023
Public Version Number: 4
DI Record Publish Date: September 07, 2016