AccessGUDID - DEVICE: Ready Sensor™ GOLD Calcium Sensor (00630414510293)

GUDID

Device Identifier (DI) Information

Brand Name: Ready Sensor™ GOLD Calcium Sensor
Version or Model: 10315219
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1428622
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414510293
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Ready Sensor™ Calcium Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments

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?
59239	Calcium (Ca2+) electrode IVD	An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of calcium (Ca2+) ions in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGA	GLUCOSE OXIDASE, GLUCOSE
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
KHP	ACID, LACTIC, ENZYMATIC METHOD
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031560	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 away from sunlight
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ea591ae1-ca82-4f8b-8ef5-2d6508da07f3
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016