FDA UDI In Commercial Distribution 🇺🇸 United States

Membrane for E1001 electrode

DI: 05700699420589 · Model: 942-058 · Radiometer Medical ApS
Product Codes
11
GMDN Terms
1
Identifiers
2
Pkg Device Count
4

Basic Information

Brand Name
Membrane for E1001 electrode
Primary DI
05700699420589
Version / Model
942-058
Catalog Number
942-058
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
bb73e673-bc06-4556-ab20-9bcfa8894742

Device Description

D711 Ref 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
CGA GLUCOSE OXIDASE, GLUCOSE
KQI ASSAY, FETAL HEMOGLOBIN
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CIG DIAZO COLORIMETRY, BILIRUBIN
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
GHS ASSAY, CARBOXYHEMOGLOBIN
KHP ACID, LACTIC, ENZYMATIC METHOD
JFP ELECTRODE, ION SPECIFIC, CALCIUM
JGS ELECTRODE, ION SPECIFIC, SODIUM

GMDN Terms

Code Name
59241 Reference electrode IVD

Identifiers

Type ID
Primary 05700699420589
Unit of Use 55700699420584

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 32 Degrees Celsius