FDA UDI Not in Commercial Distribution 🇺🇸 United States

Cleaning Solution with additive S7375 REF 944-123

DI: 05700699441232 · Model: 944-123 · Radiometer Medical ApS
Product Codes
11
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Cleaning Solution with additive S7375 REF 944-123
Primary DI
05700699441232
Version / Model
944-123
Catalog Number
944-123
Company Name
Radiometer Medical ApS
Labeler DUNS
308667539
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-21
Public Version
2
Public Version Date
2023-06-19
Public Version Status
Update
Public Device Record Key
4936892b-5bc8-4b9c-807c-89fd50427672
Distribution End Date
2022-01-05

Device Description

S7375 Cleaning Solution 175mL for ABL7XX

Device Characteristics

Single Use
Yes
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
JJS Controls for blood-gases, (assayed and unassayed)
CHL Electrode measurement, blood-gases (pco2, po2) and blood ph
CGA GLUCOSE OXIDASE, GLUCOSE
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
JFP ELECTRODE, ION SPECIFIC, CALCIUM
GKF Instrument, hematocrit, automated
JGS ELECTRODE, ION SPECIFIC, SODIUM
CIG DIAZO COLORIMETRY, BILIRUBIN
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
KHP ACID, LACTIC, ENZYMATIC METHOD

GMDN Terms

Code Name
59058 Wash/cleaning solution IVD, automated/semi-automated system

Identifiers

Type ID
Primary 05700699441232

Customer Contacts

Phone
+45999999999

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 10 Degrees Celsius
Type
Special Storage Condition, Specify
Special Conditions
Single use