FDA UDI In Commercial Distribution 🇺🇸 United States

ROSC-U Wheeled/Storage Case

DI: 00860000876285 · Model: A03-WB-000 · RESUSCITATION INTERNATIONAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ROSC-U Wheeled/Storage Case
Primary DI
00860000876285
Version / Model
A03-WB-000
Catalog Number
A03-WB-000
Company Name
RESUSCITATION INTERNATIONAL, LLC
Labeler DUNS
053006828
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-12-13
Public Version
1
Public Version Date
2019-12-23
Public Version Status
New
Public Device Record Key
b32a263c-ad6e-440f-ab88-3408fc401f92

Device Description

Case for storage/transport of ROSC-U, with wheels

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
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
DRM Compressor, Cardiac, External

GMDN Terms

Code Name
61908 Cardiac resuscitator, battery-powered

Identifiers

Type ID
Primary 00860000876285