FDA UDI In Commercial Distribution 🇺🇸 United States

TensRx Complete 4in1

DI: 00092237620465 · Model: DI8177-TRX · COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
32

Basic Information

Brand Name
TensRx Complete 4in1
Primary DI
00092237620465
Version / Model
DI8177-TRX
Company Name
COMPASS HEALTH BRANDS CORP.
Labeler DUNS
827221698
Distribution Status
In Commercial Distribution
Device Count in Pkg
32
Record Status
Published
Publish Date
2018-08-23
Public Version
7
Public Version Date
2023-09-06
Public Version Status
Update
Public Device Record Key
2eee42f6-29bb-4857-8acf-1d6f91020905

Device Description

Private labeled Select Combo for TENS Rx

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
No
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

GMDN Terms

Code Name
46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

Identifiers

Type ID
Primary 00092237620465
Package 80092237620461
Unit of Use 01092237620464

Customer Contacts

Phone
800-376-7263