MICROLET® 81264857, 81264954 (US)

GUDID 40301936586124

Colored lancets. Silicone-coated lancets. Use with the MICROLET Family of lancing devices.

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 ID40301936586124
NIH Device Record Key55dfab27-fce9-4952-97fc-e7516661e22c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMICROLET®
Version Model Number6586 / 6586W
Catalog Number81264857, 81264954 (US)
Company DUNS080028910
Company NameASCENSIA DIABETES CARE US INC.
Device Count100
DM Exemptfalse
Pre-market Exempttrue
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-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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.

Device Identifiers

Device Issuing AgencyDevice ID
GS100301936586010 [Unit of Use]
GS100301936586218 [Primary]
NDC/NHRIC0193-6586-21 [Secondary]
GS140301936586124 [Package]
Contains: 00301936586218
Package: shipper/case [12 Units]
In Commercial Distribution
GS140301936586216 [Package]
Contains: 00301936586218
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 Steriletrue

Device Entry Metadata

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

Devices Manufactured by ASCENSIA DIABETES CARE US INC.

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40301939732016 - CONTOUR® NEXT GEN2023-07-31 "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, 10 CONTOU
40301939660517 - CONTOUR® NEXT EZ, CONTOUR® NEXT GEN and CONTOUR® NEXT2022-12-01 Mixed product shipper case containing 3 CONTOUR® NEXT EZ Blood Glucose Monitoring System kits (Primary DI Number 00301939628014
40301939725254 - CONTOUR®2022-10-07 Blood Glucose Test strips. 25 test strips.
00301937917011 - CONTOUR® NEXT GEN2022-07-11 Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR®
40301937383012 - CONTOUR® NEXT GEN2022-07-08 "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, 20 CONTOU
40301939658019 - CONTOUR® NEXT GEN2022-07-08 "Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR®
00301933536018 - CONTOUR® DIABETES APP2022-02-28 Diabetes Management Software

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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