FDA UDI In Commercial Distribution 🇺🇸 United States

Winmate

DI: 00817613021311 · Model: W1500M · MED X CHANGE, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Winmate
Primary DI
00817613021311
Version / Model
W1500M
Catalog Number
W1500M
Company Name
MED X CHANGE, INC.
Labeler DUNS
051244569
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-03-31
Public Version
2
Public Version Date
2022-10-24
Public Version Status
Update
Public Device Record Key
620b357e-b6d9-4301-b1cc-4312241d0d17

Device Description

W1500M Winmate Display

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
Yes
Has Serial Number
No
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

GMDN Terms

Code Name
36612 Image display unit, colour

Identifiers

Type ID
Primary 00817613021311