FDA UDI In Commercial Distribution 🇺🇸 United States

Homedics

DI: 00031262099136 · Model: MCS-950HJ · Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Homedics
Primary DI
00031262099136
Version / Model
MCS-950HJ
Company Name
Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.
Labeler DUNS
544356011
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-07-20
Public Version
1
Public Version Date
2020-07-28
Public Version Status
New
Public Device Record Key
a814c6ef-47ed-45ff-b1ef-b0468e211b39

Device Description

MASSAGE CUSHION AND CORDLESS BODY MASSAGER WITH SOOTHING HEAT

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
PM Exempt
Yes
Has Serial Number
No
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
ISA Massager, Therapeutic, Electric

GMDN Terms

Code Name
34488 Bed/chair electric massager

Identifiers

Type ID
Package 10031262099133
Primary 00031262099136