AccessGUDID - DEVICE: Anthem Generator (00858340006219)

GUDID

Device Identifier (DI) Information

Brand Name: Anthem Generator
Version or Model: 32-500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Del Medical, Inc.

Primary DI Number: 00858340006219
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078671236 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37605	Diagnostic x-ray system generator, mobile	An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a mobile x-ray system, e.g., a system designed to be pushed or driven to various locations within a facility. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). It includes transformer, inverter, and capacitor discharge generator designs. It typically comprises a control assembly (console) and high voltage transformer assembly or is of a mono-tank generator design. This generator is an integral component of a mobile diagnostic x-ray system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZO	Generator, High-Voltage, X-Ray, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: db1cfad5-d9e1-4294-b3cc-9ce16976c392
Public Version Date: April 25, 2022
Public Version Number: 1
DI Record Publish Date: April 15, 2022