AccessGUDID - DEVICE: DentaPure 365-Day Independent Water Bottle Cartridge (D711DPI365B0)

GUDID

Device Identifier (DI) Information

Brand Name: DentaPure 365-Day Independent Water Bottle Cartridge
Version or Model: DPI365B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DPI365B
Company Name: MEDIVATORS INC.

Primary DI Number: D711DPI365B0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use

Device Description: Water Bottle Cartridge, International

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:	Yes
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?
62906	Dental waterline disinfectant cartridge	A device in the form of a cartridge containing a disinfectant (e.g., iodine resin) intended to be integrated within a dental waterline (i.e., water fed to certain dental instruments) to maintain disinfection of the water prior to patient contact through introduction of the disinfectant. This is a disposable device not intended to be reprocessed, which has a multiple-patient use application (reusable).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIA	Unit, operative dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992893	000

Device Exempt from Premarket Submission: No 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: 3d80e60d-5799-45cd-9e76-b01757de1dcf
Public Version Date: October 04, 2023
Public Version Number: 1
DI Record Publish Date: September 26, 2023