ABOUND® 7750

GUDID 40301937750517

Welcome kit - contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit (Primary DI Number 00301939763012), 1 carton of CONTOUR® NEXT ONE Blood Glucose Test Strips (Package DI Number 00301937312212), 100 MICROLET® lancets (provided sterile), recipe cards, activity cards, resistance bands (labeled latex free), relaxation mask.

ASCENSIA DIABETES CARE US INC.

Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip
Primary Device ID40301937750517
NIH Device Record Key71716812-717e-4394-b402-760179b7e698
Commercial Distribution StatusIn Commercial Distribution
Brand NameABOUND®
Version Model Number7750
Catalog Number7750
Company DUNS080028910
Company NameASCENSIA DIABETES CARE US INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com
Phone1-888-890-8577
Emailsupport@contournext.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS140301937750517 [Primary]

FDA Product Code

FMKLancet, Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-14
Device Publish Date2019-06-06

On-Brand Devices [ABOUND®]

40301937750517Welcome kit - contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit (Primary DI Numbe
50301937770512Welcome kit - contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit (Primary DI Numbe

Trademark Results [ABOUND]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ABOUND
ABOUND
98480863 not registered Live/Pending
Abound Diagnostics, Inc.
2024-04-02
ABOUND
ABOUND
98105528 not registered Live/Pending
TClub Inc.
2023-07-27
ABOUND
ABOUND
97918673 not registered Live/Pending
REPLOGIC, INC.
2023-05-03
ABOUND
ABOUND
90510533 not registered Live/Pending
Carrier Corporation
2021-02-04
ABOUND
ABOUND
90360235 not registered Live/Pending
Track Technologies, Inc.
2020-12-04
ABOUND
ABOUND
88979814 not registered Live/Pending
REPLOGIC, INC.
2019-02-04
ABOUND
ABOUND
88880429 not registered Live/Pending
Foley Family Wines, Inc.
2020-04-21
ABOUND
ABOUND
88844507 not registered Live/Pending
Cable One, Inc.
2020-03-23
ABOUND
ABOUND
88440021 not registered Live/Pending
New West Genetics, Inc.
2019-05-21
ABOUND
ABOUND
88328090 not registered Live/Pending
Fort Knox Federal Credit Union
2019-03-06
ABOUND
ABOUND
88288625 not registered Live/Pending
REPLOGIC, INC.
2019-02-04
ABOUND
ABOUND
87418419 not registered Live/Pending
Skymill Energy, Inc.
2017-04-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.