FDA UDI In Commercial Distribution 🇺🇸 United States

HealthMyne QIDS

DI: B198HM0080 · Model: 8.0 · HEALTHMYNE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HealthMyne QIDS
Primary DI
B198HM0080
Version / Model
8.0
Company Name
HEALTHMYNE, INC.
Labeler DUNS
078786040
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-06-19
Public Version
2
Public Version Date
2023-10-18
Public Version Status
Update
Public Device Record Key
167c8095-5c8c-4dd9-a47c-6b4a1b72c166

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LLZ System, Image Processing, Radiological

GMDN Terms

Code Name
41670 Radiological PACS software

Identifiers

Type ID
Primary B198HM0080