FDA UDI In Commercial Distribution 🇺🇸 United States

MDU5 PLUS

DI: 08714729982876 · Model: H749MDU5PLUSFZ0 · BOSTON SCIENTIFIC CORPORATION
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MDU5 PLUS
Primary DI
08714729982876
Version / Model
H749MDU5PLUSFZ0
Catalog Number
H749MDU5PLUSFZ0
Company Name
BOSTON SCIENTIFIC CORPORATION
Labeler DUNS
021717889
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-11-29
Public Version
1
Public Version Date
2021-12-07
Public Version Status
New
Public Device Record Key
a2ce22b4-d1fb-497b-b939-c8a836f57df3

Device Description

Motordrive Unit

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
Yes
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
DSK COMPUTER, BLOOD-PRESSURE
ITX Transducer, ultrasonic, diagnostic
DQK Computer, diagnostic, programmable
IYO System, imaging, pulsed echo, ultrasonic

GMDN Terms

Code Name
40763 Cardiovascular ultrasound imaging system

Identifiers

Type ID
Primary 08714729982876