AccessGUDID - DEVICE: Eurotrol epoc GAS-ISE Metabolites (08718734960751)

GUDID

Device Identifier (DI) Information

Brand Name: Eurotrol epoc GAS-ISE Metabolites
Version or Model: Level 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 266.002.010
Company Name: Eurotrol B.V.

Primary DI Number: 08718734960751
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 412925992 *Terms of Use

Device Description: Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 2 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.

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):	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?
52860	Multiple blood gas/haemoximetry/electrolyte analyte IVD, control	A material which is used to verify the performance of an assay intended to be 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
JJY	Multi-Analyte Controls, All Kinds (Assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121468	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: df8d15a5-74f9-410c-bd8e-52e95132ceb3
Public Version Date: August 13, 2018
Public Version Number: 1
DI Record Publish Date: July 11, 2018