AccessGUDID - DEVICE: RAPIDLab® 1200 pH Electrode Fill (00630414570495)

GUDID

Device Identifier (DI) Information

Brand Name: RAPIDLab® 1200 pH Electrode Fill
Version or Model: 10376881
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10376881
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414570495
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: pH electrode fill soultion, in vitro diagnostics material for use with RAPIDLab® 1200 series electrodes

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?
59243	Hydrogen (H+)/pH electrode IVD	An electrochemical sensor, also referred to as a calomel electrode, intended to be used to selectively measure electrical potential across a permeable membrane to determine the pH, or the concentration of hydrogen (H+) ions in a clinical specimen.	Active	false

FDA Product Code

[?]

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

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: 321ca3ab-a9f6-4f28-9f4d-931ffb67bc9e
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016