AccessGUDID - DEVICE: CLINITEK Status® Connector (00630414578330)

GUDID

Device Identifier (DI) Information

Brand Name: CLINITEK Status® Connector
Version or Model: 10376323
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10376323
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414578330
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzers. The connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR).

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?
57861	Urine analyser IVD, point-of-care	A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEN	DYE-INDICATOR, PH (URINARY, NON-QUANT.)
JIP	BLOOD, OCCULT, ENZYMATIC METHOD, IN URINE
JHI	Visual, pregnancy hCG, prescription use
CDM	DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
KQO	AUTOMATED URINALYSIS SYSTEM
LJX	TEST, URINE LEUKOCYTE
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
JMT	DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
JRE	REFRACTOMETER FOR CLINICAL USE
JJB	AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
JIL	METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
JFY	ENZYMATIC METHOD, CREATININE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091216	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: Max 95% RH at 45'c
Storage Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bec62ad8-a7cc-4b80-8110-da2acc268ce8
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016