FDA UDI In Commercial Distribution 🇺🇸 United States

TENS 7000 Bulk Electrode - 16 total

DI: 00092237621035 · Model: DT7202-ELEC16 · COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
16

Basic Information

Brand Name
TENS 7000 Bulk Electrode - 16 total
Primary DI
00092237621035
Version / Model
DT7202-ELEC16
Company Name
COMPASS HEALTH BRANDS CORP.
Labeler DUNS
827221698
Distribution Status
In Commercial Distribution
Device Count in Pkg
16
Record Status
Published
Publish Date
2018-08-10
Public Version
3
Public Version Date
2023-09-11
Public Version Status
Update
Public Device Record Key
d6a9b084-ddfa-48e9-99ed-ef88049d7f0e

Device Description

TENS 7000 OTC Bulk Electrodes - 4 packs of 4 = Total of 16 individual electrodes.

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
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
No
Sterilization Prior Use
No

Product Codes

Code Name
GXY Electrode, Cutaneous

GMDN Terms

Code Name
35995 Transcutaneous electrical stimulation electrode, single-use

Identifiers

Type ID
Package 80092237621031
Package 30092237621036
Primary 00092237621035
Unit of Use 01092237621034

Customer Contacts

Phone
800-376-7263