FDA UDI In Commercial Distribution 🇺🇸 United States

BodyMed

DI: 00815991020377 · Model: ZZAEV810 · BOXOUT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
BodyMed
Primary DI
00815991020377
Version / Model
ZZAEV810
Catalog Number
ZZAEV810
Company Name
BOXOUT, LLC
Labeler DUNS
066689993
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-12
Public Version
8
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
63af98f6-b4eb-401d-a2a3-bff5ce14dada

Device Description

Fully digital BodyMed TENS unit, ZZAEV810, 10 programs, includes a carrying case, an adapter and two 9 V batteries

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
No
Has Expiration Date
No
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 00815991020377
Package 10815991020367
Package 20815991020364

Customer Contacts

Phone
866-528-2153