AccessGUDID - DEVICE: EPOC BGEM CREA TEST CARD (00809708072254)

GUDID

Device Identifier (DI) Information

Brand Name: EPOC BGEM CREA TEST CARD
Version or Model: CT-1006-00-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CT-1006-00-00
Company Name: Epocal Inc

Primary DI Number: 00809708072254
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 201179681 *Terms of Use

Device Description: EPOC BGEM CREA TEST CARD

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:	Yes
Prescription Use (Rx):	Yes
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?
52861	Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEM	Electrode, Ion Specific, Potassium
CGA	Glucose Oxidase, Glucose
CGZ	Electrode, Ion-Specific, Chloride
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
JFP	Electrode, Ion Specific, Calcium
JGS	Electrode, Ion Specific, Sodium
KHP	Acid, Lactic, Enzymatic Method

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 7f180f18-39bd-4c3f-968e-2ee903cfbc6f
Public Version Date: November 19, 2021
Public Version Number: 4
DI Record Publish Date: August 17, 2016