FDA UDI In Commercial Distribution 🇺🇸 United States

Kozee

DI: 08973920006556 · Model: M21006 · SOURCEMARK, LLC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Kozee
Primary DI
08973920006556
Version / Model
M21006
Company Name
SOURCEMARK, LLC.
Labeler DUNS
121225812
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-01-27
Public Version
3
Public Version Date
2021-12-06
Public Version Status
Update
Public Device Record Key
2c1e39cb-27df-48ef-a5a8-f2bcbc86bfa5

Device Description

Full Access Under Body Warming Blanket

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DWJ System, Thermal Regulating

GMDN Terms

Code Name
36954 Circulating-air whole-body heating system control unit

Identifiers

Type ID
Package 18973920006805
Primary 08973920006556