AccessGUDID - DEVICE: CLINITEK Status® Connector (00630414571263)

GUDID

Device Identifier (DI) Information

Brand Name: CLINITEK Status® Connector
Version or Model: 10376322
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10376322
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414571263
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 andcentralized 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?
56677	Multichannel clinical chemistry analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents and incorporates multiple channels using two or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence.	Obsolete	false

FDA Product Code

[?]

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

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
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1012d2fc-e5ba-46fb-ae70-add6a16ed0d3
Public Version Date: September 16, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016