KETOCOACH 50 BLOOD KETONE TEST STRIPS

GUDID 00860060002327

AMVENTUREX, INC.

Ketone (acetoacetate) IVD, reagent
Primary Device ID00860060002327
NIH Device Record Key5fd3d4b7-3c10-4ed2-afe5-43c5b63d41f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameKETOCOACH 50 BLOOD KETONE TEST STRIPS
Version Model NumberS5640791
Company DUNS117225590
Company NameAMVENTUREX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100860060002327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JINNitroprusside, Ketones (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-07
Device Publish Date2019-12-30

Devices Manufactured by AMVENTUREX, INC.

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00850017460027 - BIOCOACH Blood Glucose Test Strips 50s2022-01-05 50s
00850017460034 - BIOCOACH Blood Glucose and Ketone Monitoring System2022-01-05 Complete Kit
00850017460058 - BIOCOACH Glucose Control Solution L1/L22022-01-05 Level 1 & 2
00850017460065 - BIOCOACH Blood Glucose Test Strips 25s2022-01-05 25s
00860060002310 - KETOCOACH BLOOD KETONE METER2020-01-07
00860060002327 - KETOCOACH 50 BLOOD KETONE TEST STRIPS2020-01-07
00860060002327 - KETOCOACH 50 BLOOD KETONE TEST STRIPS2020-01-07

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