FDA UDI Not in Commercial Distribution 🇺🇸 United States

Electrode for ABL analyzers

DI: 05700699453761 · Model: 945-376 · Radiometer Medical ApS
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Electrode for ABL analyzers
Primary DI
05700699453761
Version / Model
945-376
Catalog Number
945-376
Company Name
Radiometer Medical ApS
Labeler DUNS
308667539
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-01
Public Version
4
Public Version Date
2022-06-22
Public Version Status
Update
Public Device Record Key
455e3d64-a9eb-4712-b280-31b278f1424a
Distribution End Date
2020-01-16

Device Description

E909 pO2 electrode Color-coded Red. for ABL5/50/5XX

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
No
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
JGS ELECTRODE, ION SPECIFIC, SODIUM
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CGA GLUCOSE OXIDASE, GLUCOSE

GMDN Terms

Code Name
54501 Blood gas pO2 IVD, kit, ion-selective electrode (ISE)

Identifiers

Type ID
Primary 05700699453761

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 32 Degrees Celsius