AccessGUDID - DEVICE: Ready Sensor™ Glucose Biosensor (00630414112343)

GUDID

Device Identifier (DI) Information

Brand Name: Ready Sensor™ Glucose Biosensor
Version or Model: 10320748
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 476378
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414112343
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: In vitro diagnostics medical device. For measurement of glucose 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?
30203	Laboratory pH electrode	A clinical chemistry, electrolyte, electrode type biosensor, typically used in the laboratory for measuring pH. This is a reusable device.	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Do not freeze

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 94d24c46-2cbc-41fe-b9fb-f9cf8c62fe6f
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016