AccessGUDID - DEVICE: Ready Sensor™ Lactate Biosensor (00630414468143)

GUDID

Device Identifier (DI) Information

Brand Name: Ready Sensor™ Lactate Biosensor
Version or Model: 10316526
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2144067
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414468143
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Ready Sensor™ Lactate Biosensor is an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems.

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?
30208	Lactate electrode IVD	An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of lactate ions in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K934907	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: Do not freeze
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4adf0ea6-4ebe-4699-8981-ffc76b229d4d
Public Version Date: November 19, 2021
Public Version Number: 6
DI Record Publish Date: September 24, 2016