FDA UDI In Commercial Distribution 🇺🇸 United States

MDU5 PLUS Sterile Bag

DI: 08714729842255 · Model: H749MDU5PLUSBAG0 · BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MDU5 PLUS Sterile Bag
Primary DI
08714729842255
Version / Model
H749MDU5PLUSBAG0
Company Name
BOSTON SCIENTIFIC CORPORATION
Labeler DUNS
021717889
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
b3d82dfb-8c6b-4f43-81b9-8e217b0bd299

Device Description

Sterile bag for MDU5 PLUS Motordrive

Device Characteristics

Single Use
Yes
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
Yes
Sterilization Prior Use
No

Product Codes

Code Name
IYO System, imaging, pulsed echo, ultrasonic

GMDN Terms

Code Name
45021 Instrument/equipment drape, single-use, sterile

Identifiers

Type ID
Primary 08714729842255