AccessGUDID - DEVICE: POWERPRO (10845854041451)

GUDID

Device Identifier (DI) Information

Brand Name: POWERPRO
Version or Model: PRO3600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRO3600
Company Name: Conmed Corporation

Primary DI Number: 10845854041451
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use
Previous DI: 20845854041458

Device Description: PowerPro Battery Charger Universal Voltage

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):	Yes
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?
17115	Noninvasive device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAB	SAW, POWERED, AND ACCESSORIES

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
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 53cf5e20-de79-42b4-82a3-d0fd4a96d30b
Public Version Date: March 27, 2024
Public Version Number: 5
DI Record Publish Date: June 29, 2022