FDA UDI In Commercial Distribution 🇺🇸 United States

ER9W CDMA wEvent

DI: B146ER9WCNC0 · Model: 900-0612-01 · BRAEMAR MANUFACTURING, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ER9W CDMA wEvent
Primary DI
B146ER9WCNC0
Version / Model
900-0612-01
Company Name
BRAEMAR MANUFACTURING, LLC
Labeler DUNS
049529118
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-07-15
Public Version
1
Public Version Date
2020-07-23
Public Version Status
New
Public Device Record Key
f5e4b3dd-432d-4ab5-afd3-504c9a65703e

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

GMDN Terms

Code Name
31733 Electrocardiography telemetric monitoring system

Identifiers

Type ID
Primary B146ER9WCNC0