FDA UDI In Commercial Distribution 🇺🇸 United States

NDDR and CDCS

DI: 00860011763208 · Model: 2.3 · CIELOWORKS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NDDR and CDCS
Primary DI
00860011763208
Version / Model
2.3
Company Name
CIELOWORKS, INC.
Labeler DUNS
102958199
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-07-16
Public Version
1
Public Version Date
2025-07-24
Public Version Status
New
Public Device Record Key
7c70f1fe-7fa2-46f3-afc3-5e9402b4cc68

Device Description

NDDR and CDCS is a web-based application that is intended to meet the needs of participating donation centers to check for the presence of recent blood or blood components (including plasma) donations at other donation centers by a prospective donor, as well as check if prospective donors have been deferred by participating donation centers.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
Yes
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
MMH Blood Establishment Computer Software And Accessories

GMDN Terms

Code Name
44100 Blood bank information system application software

Identifiers

Type ID
Primary 00860011763208