AccessGUDID - DEVICE: Ready Sensor™ GOLD Hct Sensor (00630414056296)

GUDID

Device Identifier (DI) Information

Brand Name: Ready Sensor™ GOLD Hct Sensor
Version or Model: 10309783
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 106042
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414056296
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Ready Sensor™ Hct Biosensor for in vitro use on the RapidLab® 348/348ex pH/Blood Gas Analyzers.

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?
35933	Multiple blood gas analyte IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962021	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: b0919956-9a4b-44a0-bc85-8ca4a03d9993
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016