FDA UDI Not in Commercial Distribution 🇺🇸 United States

Calibration Solution

DI: 05700699440259 · Model: 944-025 · Radiometer Medical ApS
Product Codes
11
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Calibration Solution
Primary DI
05700699440259
Version / Model
944-025
Catalog Number
944-025
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
2023-04-24
Public Version Status
Update
Public Device Record Key
6d4f8fd6-cb94-4031-879a-208257bb6ec3
Distribution End Date
2023-02-21

Device Description

S1730 Calibration Solution 2 200 mL, for ABL7XX

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
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
JJS CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
KHP ACID, LACTIC, ENZYMATIC METHOD
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
JGS ELECTRODE, ION SPECIFIC, SODIUM
CGA GLUCOSE OXIDASE, GLUCOSE
CIG DIAZO COLORIMETRY, BILIRUBIN
GKF INSTRUMENT, HEMATOCRIT, AUTOMATED
JFP ELECTRODE, ION SPECIFIC, CALCIUM

GMDN Terms

Code Name
35933 Multiple blood gas analyte IVD, calibrator

Identifiers

Type ID
Primary 05700699440259

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 25 Degrees Celsius