AccessGUDID - DEVICE: CLINITEK Atlas® Control+ Strips (00630414373201)

GUDID

Device Identifier (DI) Information

Brand Name: CLINITEK Atlas® Control+ Strips
Version or Model: 10311124
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5019
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414373201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Quality control for CLINITEK Atlas® and CLINITEK Novus® analyzers

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):	No
Over the Counter (OTC):	No
Kit:	No
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
KQO	AUTOMATED URINALYSIS SYSTEM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K932674	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
Special Storage Condition, Specify: Keep out of direct sunlight
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 41e0995d-8729-472f-b774-0a6bdf415a58
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016