FDA UDI In Commercial Distribution 🇺🇸 United States

Zewa

DI: 00682891210227 · Model: 21022 · ZEWA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Zewa
Primary DI
00682891210227
Version / Model
21022
Company Name
ZEWA, INC.
Labeler DUNS
013481078
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-12-13
Public Version
6
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
0e6cea52-34ee-45c1-b1b8-35f970e74abc

Device Description

TENS Unit 21022

Device Characteristics

Single Use
Yes
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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

GMDN Terms

Code Name
46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

Identifiers

Type ID
Primary 00682891210227