GLUCOPAD TC-SMART+ Lancets Kit G852-E-001

GUDID 10673486002478

Each GLUCOPAD TC-SMART+ Lancets Kit has 100 pcs per kit. The intended use is for capillary blood sampling on a patient age 6 months and up. Lancet is for single use only.

TECO DIAGNOSTICS

Blood lancet, single-use
Primary Device ID10673486002478
NIH Device Record Key966120af-64dc-498e-af58-e616bfe10b17
Commercial Distribution StatusIn Commercial Distribution
Brand NameGLUCOPAD TC-SMART+ Lancets Kit
Version Model NumberG852-E-001
Catalog NumberG852-E-001
Company DUNS185067774
Company NameTECO DIAGNOSTICS
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-222-9880
Emailhello@tecodiagnostics.com
Phone800-222-9880
Emailhello@tecodiagnostics.com
Phone800-222-9880
Emailhello@tecodiagnostics.com
Phone800-222-9880
Emailhello@tecodiagnostics.com
Phone800-222-9880
Emailhello@tecodiagnostics.com
Phone800-222-9880
Emailhello@tecodiagnostics.com
Phone800-222-9880
Emailhello@tecodiagnostics.com
Phone800-222-9880
Emailhello@tecodiagnostics.com
Phone800-222-9880
Emailhello@tecodiagnostics.com
Phone800-222-9880
Emailhello@tecodiagnostics.com
Phone800-222-9880
Emailhello@tecodiagnostics.com
Phone800-222-9880
Emailhello@tecodiagnostics.com
Phone800-222-9880
Emailhello@tecodiagnostics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110673486002478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2025-06-18
Device Publish Date2025-06-10

On-Brand Devices [GLUCOPAD TC-SMART+ Lancets Kit]

10673486002461Each GLUCOPAD TC-SMART+ Lancets Kit has 50 pcs per kit. The intended use is for capillary blood
10673486002478Each GLUCOPAD TC-SMART+ Lancets Kit has 100 pcs per kit. The intended use is for capillary bloo

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.