FDA UDI Not in Commercial Distribution 🇺🇸 United States

Flex-IT Retail 022017

DI: 00858688006940 · Model: FLEI0001R02 · Emsi
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Flex-IT Retail 022017
Primary DI
00858688006940
Version / Model
FLEI0001R02
Company Name
Emsi
Labeler DUNS
932471881
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-05-16
Public Version
8
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
4f9d4d2c-464f-49df-93f2-005976ebf588
Distribution End Date
2017-05-16

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
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
LIH Interferential Current Therapy

GMDN Terms

Code Name
46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

Identifiers

Type ID
Primary 00858688006940

Premarket Submissions

Submission Number Supplement Number
K071869 000