AccessGUDID - DEVICE: TB4 Glu/Lac Test/Blank Sensor (00630414132051)

GUDID

Device Identifier (DI) Information

Brand Name: TB4 Glu/Lac Test/Blank Sensor
Version or Model: 10326708
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 673701000
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414132051
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Blank Sensor used For GLU or LAC on 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
KHP	ACID, LACTIC, ENZYMATIC METHOD
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CGA	GLUCOSE OXIDASE, GLUCOSE

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8a7251e1-1450-4e55-a8e6-e7f70a4080ea
Public Version Date: November 19, 2021
Public Version Number: 6
DI Record Publish Date: September 24, 2016