InSure® ONE™ 14103.01

GUDID 00850093003293

InSure® ONE™ Run Buffer - 1 Liter Bottle

ENTERIX INC.

Faecal occult blood IVD, reagent
Primary Device ID00850093003293
NIH Device Record Keya49db22f-fdc1-488a-9ea3-6ac6b1cd717d
Commercial Distribution StatusIn Commercial Distribution
Brand NameInSure® ONE™
Version Model Number01
Catalog Number14103.01
Company DUNS002224009
Company NameENTERIX INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18005313681
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850093003293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KHEReagent, Occult Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-05

On-Brand Devices [InSure® ONE™]

00850093003354InSure® ONE™ Combo Pack - contains 35 Collection Kits and 1 Developer Kit
00850093003347InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in a sealed, bu
30850093003317InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027.01, 15240.01
00850093003309InSure® ONE™ Sample Kit - NOT FOR SALE Contains 2 Collection Kits, 2 individually-pouched Tes
00850093003293InSure® ONE™ Run Buffer - 1 Liter Bottle
00850093003286InSure® ONE™ Test Cards for QC - 50 pack
00850093003279InSure® ONE™ Combo Pack - contains 25 Collection Kits and 1 Developer Kit
00850093003231InSure® ONE™ Developer Kit - contains 25 individually-pouched Test Strips and 1 bottle of Run

Trademark Results [InSure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INSURE
INSURE
98041149 not registered Live/Pending
Curtiss-Wright Flow Control Corporation
2023-06-13
INSURE
INSURE
86901380 5044834 Live/Registered
Enterix, Inc.
2016-02-08
INSURE
INSURE
78232524 2909232 Dead/Cancelled
Enterix Inc.
2003-04-01
INSURE
INSURE
78232512 2978654 Live/Registered
Enterix Inc.
2003-04-01
INSURE
INSURE
78165733 2732347 Live/Registered
Brandt Consolidated, Inc.
2002-09-19
INSURE
INSURE
77920655 not registered Dead/Abandoned
WARBINGTON, TIMOTHY
2010-01-26
INSURE
INSURE
77726007 4364957 Live/Registered
Geovada LLC
2009-04-30
INSURE
INSURE
77118666 not registered Dead/Abandoned
W.C. Bradley Company
2007-02-28
INSURE
INSURE
77118438 not registered Indifferent
W.C. Bradley Company
0000-00-00
INSURE
INSURE
76533458 not registered Dead/Abandoned
Botanical Laboratories, Inc.
2003-07-30
INSURE
INSURE
76494198 not registered Dead/Abandoned
Mannington Carpets, Inc.
2003-03-03
INSURE
INSURE
76024894 2675417 Dead/Cancelled
SCHWAN'S IP, LLC
2000-04-13

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