AccessGUDID - DEVICE: Clinitek Status Connector (00630414607962)

GUDID

Device Identifier (DI) Information

Brand Name: Clinitek Status Connector
Version or Model: 11537761
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11537761
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414607962
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+ analyzerThe connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS)and interfaces with Electronic Medical Records (EMR).The CLINITEK Status Connector and CLINITEK Status+ analyzer together are the CLINITEK Status Connect 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):	Yes
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
JJB	AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
CEN	Dye-indicator, pH (urinary, non-quantitative)
JFY	ENZYMATIC METHOD, CREATININE
CDM	DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
JMT	DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
JHI	Visual, pregnancy hCG, prescription use
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
KQO	AUTOMATED URINALYSIS SYSTEM
JIP	BLOOD, OCCULT, ENZYMATIC METHOD, IN URINE
JRE	REFRACTOMETER FOR CLINICAL USE
LJX	TEST, URINE LEUKOCYTE

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
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between 5 and 40 Degrees Celsius
Special Storage Condition, Specify: max 95% RH at 45 'C

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 80ef26a6-cc56-4442-b9df-1f76c69b7c06
Public Version Date: November 19, 2021
Public Version Number: 2
DI Record Publish Date: September 30, 2020