FDA UDI In Commercial Distribution 🇺🇸 United States

Membrane for E788 electrode

DI: 05700699420633 · Model: 942-063 · Radiometer Medical ApS
Product Codes
12
GMDN Terms
1
Identifiers
2
Pkg Device Count
4

Basic Information

Brand Name
Membrane for E788 electrode
Primary DI
05700699420633
Version / Model
942-063
Catalog Number
942-063
Company Name
Radiometer Medical ApS
Labeler DUNS
308667539
Distribution Status
In Commercial Distribution
Device Count in Pkg
4
Record Status
Published
Publish Date
2016-09-01
Public Version
3
Public Version Date
2020-11-27
Public Version Status
Update
Public Device Record Key
e3864f4b-1601-4fe9-bb07-f480ff92c767

Device Description

D788 pCO2 membrane box (4 units) for ABL7XX/8XX

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

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

GMDN Terms

Code Name
54500 Blood gas pCO2 IVD, kit, ion-selective electrode (ISE)

Identifiers

Type ID
Primary 05700699420633
Unit of Use 55700699420638

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 32 Degrees Celsius