FDA UDI In Commercial Distribution 🇺🇸 United States

CASE MEDICAL

DI: 00653159008139 · Model: ME04KIT · Case Medical Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CASE MEDICAL
Primary DI
00653159008139
Version / Model
ME04KIT
Catalog Number
ME04KIT
Company Name
Case Medical Inc.
Labeler DUNS
053057972
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-03-21
Public Version
7
Public Version Date
2023-10-19
Public Version Status
Update
Public Device Record Key
3692a9ad-66a2-4a8e-9faa-75d1b3e1a047

Device Description

MEDICAL ENTERPRISES BATTERY TRAY DISPOSABLE KIT

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
13730 Device sterilization/disinfection container, reusable

Identifiers

Type ID
Primary 00653159008139