AccessGUDID - DEVICE: Membrane for E7077 electrode (05700699420664)

GUDID

Device Identifier (DI) Information

Brand Name: Membrane for E7077 electrode
Version or Model: 942-066
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 942-066
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699420664
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: D7077 Lac membrane box (4 units) for ABL7XX/8XX

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):	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?
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
JGS	ELECTRODE, ION SPECIFIC, SODIUM
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
GHS	ASSAY, CARBOXYHEMOGLOBIN
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CIG	DIAZO COLORIMETRY, BILIRUBIN
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
CGA	GLUCOSE OXIDASE, GLUCOSE
KQI	ASSAY, FETAL HEMOGLOBIN

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
Storage Environment Temperature: between 2 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 64b6d69d-25ee-4e85-9da6-a900f254c99d
Public Version Date: March 19, 2021
Public Version Number: 4
DI Record Publish Date: September 01, 2016