FDA UDI In Commercial Distribution 🇺🇸 United States

DST

DI: G535DSTTPX0 · Model: DST8000 Triple Pro XL · D.P.E MEDICAL LTD.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
DST
Primary DI
G535DSTTPX0
Version / Model
DST8000 Triple Pro XL
Catalog Number
DST8000 Triple Pro XL
Company Name
D.P.E MEDICAL LTD.
Labeler DUNS
532608650
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-01-20
Public Version
1
Public Version Date
2026-01-28
Public Version Status
New
Public Device Record Key
c997cb2b-3aa0-4c43-a3d8-2d895cb73d52

Device Description

DST8000 Triple Pro XL combines all the benefits of the DST Triple with the Pro system which monitors, tracks, and displays the patient’s gait and performance while practicing stairs, a slope and parallel bars.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
Yes
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
IRR Bars, Parallel, Powered

GMDN Terms

Code Name
35058 Stair-climbing exerciser, non-powered
46339 Parallel bar exerciser, powered

Identifiers

Type ID
Package G535DSTTPX1
Primary G535DSTTPX0