FDA UDI In Commercial Distribution 🇺🇸 United States

RHYTHMIA HDx™

DI: 08714729938514 · Model: M004RA5010I0 · BOSTON SCIENTIFIC CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
RHYTHMIA HDx™
Primary DI
08714729938514
Version / Model
M004RA5010I0
Company Name
BOSTON SCIENTIFIC CORPORATION
Labeler DUNS
021717889
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-05-01
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
aee0596f-494f-42af-903e-6b07757d4e16

Device Description

ECG IN Cable (Trunk)

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DSA CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE

GMDN Terms

Code Name
35562 Electrocardiographic lead set, reusable

Identifiers

Type ID
Primary 08714729938514