FDA UDI In Commercial Distribution 🇺🇸 United States

S8377 REF 944-136 *6 Cleaning solution Met II Solution

DI: 05700699441362 · Model: 944-136 · Radiometer Medical ApS
Product Codes
12
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
S8377 REF 944-136 *6 Cleaning solution Met II Solution
Primary DI
05700699441362
Version / Model
944-136
Catalog Number
944-136
Company Name
Radiometer Medical ApS
Labeler DUNS
308667539
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-21
Public Version
1
Public Version Date
2018-10-22
Public Version Status
New
Public Device Record Key
37942c5c-0aeb-4b7d-8883-e5fa06cf2021

Device Description

S8377 Cleaning MET II Solution membrane bottle , 6*100mL for ABL8XX

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
JFP ELECTRODE, ION SPECIFIC, CALCIUM
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
CGA GLUCOSE OXIDASE, GLUCOSE
GHS ASSAY, CARBOXYHEMOGLOBIN
JGS ELECTRODE, ION SPECIFIC, SODIUM
CHL Electrode measurement, blood-gases (pco2, po2) and blood ph
KQI ASSAY, FETAL HEMOGLOBIN
CIG DIAZO COLORIMETRY, BILIRUBIN
KHP ACID, LACTIC, ENZYMATIC METHOD
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE

GMDN Terms

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

Identifiers

Type ID
Package 15700699441369
Primary 05700699441362

Customer Contacts

Phone
+45999999999

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 10 Degrees Celsius