FDA UDI In Commercial Distribution 🇺🇸 United States

S4970 Rinse 1 Solution for 600mL, for ABL7xx

DI: 05700699440570 · Model: 944-057 · Radiometer Medical ApS
Product Codes
11
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
S4970 Rinse 1 Solution for 600mL, for ABL7xx
Primary DI
05700699440570
Version / Model
944-057
Catalog Number
944-057
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
71a4112b-de04-4f23-ab9a-a8983fcbb441

Device Description

Rinse Solution S4970 REF 944-057 600mL

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

GMDN Terms

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

Identifiers

Type ID
Primary 05700699440570

Customer Contacts

Phone
+45999999999

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 32 Degrees Celsius