FDA UDI In Commercial Distribution 🇺🇸 United States

Anthem Generator

DI: 00858340006257 · Model: 30-400 · Del Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Anthem Generator
Primary DI
00858340006257
Version / Model
30-400
Company Name
Del Medical, Inc.
Labeler DUNS
078671236
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-04-15
Public Version
1
Public Version Date
2022-04-25
Public Version Status
New
Public Device Record Key
37727ad5-abc4-46d4-899c-3fa76045cf7c

Device Description

The Anthem Generator is intended for use as part of a radiographic stationary x-ray system. The generator provides power and control for other parts of the system. It uses multi-pulse high frequency technology to produce waveforms near constant potential.

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
Yes
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
IZO Generator, High-Voltage, X-Ray, Diagnostic

GMDN Terms

Code Name
37605 Diagnostic x-ray system generator, mobile

Identifiers

Type ID
Primary 00858340006257