MICROLET®NEXT 85139940

GUDID 40301936702012

Lancing Device. 1 Kit: 1 MICROLET®NEXT lancing device with adjustable endcap; 5 MICROLET® sterile lancets, coated with silicone.

ASCENSIA DIABETES CARE US INC.

Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable
Primary Device ID40301936702012
NIH Device Record Key90d4a07d-393e-476e-805a-f3bd0cb7bfc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMICROLET®NEXT
Version Model Number6702
Catalog Number85139940
Company DUNS080028910
Company NameASCENSIA DIABETES CARE US INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100301936702014 [Primary]
GS140301936702012 [Package]
Contains: 00301936702014
Package: shipper/case [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMKLancet, Blood
QRLMultiple Use Blood Lancet For Single Patient Use Only

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 [MICROLET®NEXT]

40301936721013Alternative Site Testing (AST) Endcap
40301936705013Lancing Device
40301936702012Lancing Device. 1 Kit: 1 MICROLET®NEXT lancing device with adjustable endcap; 5 MICROLET® ste

Trademark Results [MICROLET]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MICROLET
MICROLET
88151546 not registered Live/Pending
Ascensia Diabetes Care Holdings AG
2018-10-11
MICROLET
MICROLET
75069425 2100253 Dead/Cancelled
BAYER CORPORATION
1996-03-08

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