FDA UDI Not in Commercial Distribution 🇺🇸 United States

EON 100 CARBON DIOXIDE REAGENT

DI: 03661540200083 · Model: 77475 · ELITECH CLINICAL SYSTEMS SAS
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
EON 100 CARBON DIOXIDE REAGENT
Primary DI
03661540200083
Version / Model
77475
Company Name
ELITECH CLINICAL SYSTEMS SAS
Labeler DUNS
267732378
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
4
Public Version Date
2023-07-06
Public Version Status
Update
Public Device Record Key
da33baa7-fc35-4358-b12a-28e1fe686b68
Distribution End Date
2020-09-16

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
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

GMDN Terms

Code Name
60768 Carbon dioxide (CO2) IVD, kit, spectrophotometry

Identifiers

Type ID
Primary 03661540200083