FDA UDI In Commercial Distribution 🇺🇸 United States

DVT-SERIES

DI: 08809315675345 · Model: DS131 · DAESUNG MAREF CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1

Basic Information

Brand Name
DVT-SERIES
Primary DI
08809315675345
Version / Model
DS131
Company Name
DAESUNG MAREF CO.,LTD.
Labeler DUNS
688817949
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-06-21
Public Version
1
Public Version Date
2021-06-29
Public Version Status
New
Public Device Record Key
ba6cb573-dd72-403d-a39c-1ed37980f284

Device Description

MULTI-USE FOOT SLEEVE, Medium, 2ea [One polybag]

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
Yes
Has Expiration Date
No
Has Donation ID
Yes

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JOW Sleeve, Limb, Compressible

GMDN Terms

Code Name
44768 Multi-chamber venous compression system garment, reusable

Identifiers

Type ID
Package 18809315675342
Primary 08809315675345
Package 28809315675349
Package 38809315675346
Package 48809315675343

Premarket Submissions

Submission Number Supplement Number
K203016 000
K203417 000