AccessGUDID - DEVICE: Clinitek Novus® Rinse Additive (00630414590936)

GUDID

Device Identifier (DI) Information

Brand Name: Clinitek Novus® Rinse Additive
Version or Model: 10697754
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10697754
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414590936
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Rinse additive for CLINITEK Novus® automated urine chemistry system.

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):	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?
58236	Buffered wash solution IVD	A buffered wash solution intended to be used as a consumable reagent in combination with other IVDs during manual procedures or on-board an automated or semi-automated instrument for the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIL	METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
JMT	DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
JRE	REFRACTOMETER FOR CLINICAL USE
JIO	BLOOD, OCCULT, COLORIMETRIC, IN URINE
CDM	DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
JJB	AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
CEN	DYE-INDICATOR, PH (URINARY, NON-QUANT.)
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
KQO	AUTOMATED URINALYSIS SYSTEM
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE
LJX	TEST, URINE LEUKOCYTE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140717	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
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: 2bff062c-f08c-4c1c-854c-542c234208ff
Public Version Date: June 02, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016