FDA.reportPublic FDA data

BluTube 180 Day Cartridge

Primary DI
00850018182089
Brand
BluTube 180 Day Cartridge
Company
PROEDGE DENTAL PRODUCTS, INC.
Model
BT180
Device description
BluTube 180 Day Cartridge
Published
2020-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018182089PackageGS110In Commercial Distribution
00850018182041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018182089008500181820898500181820890850018182089
00850018182041008500181820418500181820410850018182041

GMDN Terms#

Term, Definition table
TermDefinition
Dental water line disinfectant cartridgeA non-sterile 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18888433343richardv@proedgedental.com

Regulatory Flags#

DUNS number
050414346
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018182041BluTube 180 Day Cartridge BT1802020-05-08
00850018182072BluTube 90 Day Cartridge BT902020-05-08
00850018182003BluTab 2L TabletsBT202020-04-20
00850018182010BluTab 750mL TabletsBT50BT502020-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975220031162Dental UnitLakong Medical Devices Co., Ltd.EIA2026-10-20
06975220031179Dental UnitLakong Medical Devices Co., Ltd.EIA2026-10-20
06975659690060YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690077YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690107YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690114YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-07
00841709109805MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109812MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109843MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109850MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109874MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109881MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110030MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110054MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110061MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111846MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111853MidmarkMIDMARK CORPORATIONEIA2026-09-28
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
07898971838004OlsenOlsen Indústria e Comércio S/AEIA2026-04-22
J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
00850043433521E300 Delivery SystemEngle Dental Systems, LLCEIA2026-02-09
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-09-04
00850043433514E300 Dr./Asst Rear DeliveryEngle Dental Systems, LLCEIA2025-08-26
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
00850043433507Cabinet Side Mt Rear Delivery Asst OnlyEngle Dental Systems, LLCEIA2024-11-06
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08