AMVENTUREX, INC.

Address:225 S 6th Street,Minneapolis,MN,55402,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (5) System, Test, Blood Glucose, Over The Counter (NBW) (3) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

BIOCOACH Blood Glucose Test Strips 50s - 00850017460027 Catalog Number : S5640989

Device Description : 50s

Device Class : 2

Duns Number: 117225590

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

BIOCOACH Blood Glucose and Ketone Monitoring System - 00850017460034 Catalog Number : S84102

Device Description : Complete Kit

Device Class : 1

Duns Number: 117225590

Premarket Exempt : No

Product Code : JIN, NBW

Prescription Use : No

Device Count : 1

BIOCOACH Glucose Control Solution L1/L2 - 00850017460058 Catalog Number : S5800382

Device Description : Level 1 & 2

Device Class : 1

Duns Number: 117225590

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

BIOCOACH Blood Glucose Test Strips 25s - 00850017460065 Catalog Number : S5640988

Device Description : 25s

Device Class : 2

Duns Number: 117225590

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

KETOCOACH BLOOD KETONE METER - 00860060002310 Catalog Number :

Device Class : 1

Duns Number: 117225590

Premarket Exempt : No

Product Code : JIN

Prescription Use : No

Device Count : 1

KETOCOACH 50 BLOOD KETONE TEST STRIPS - 00860060002327 Catalog Number :

Device Class : 1

Duns Number: 117225590

Premarket Exempt : No

Product Code : JIN

Prescription Use : No

Device Count : 1

KETOCOACH CONTROL SOLUTION Level 2 - 00860060002334 Catalog Number :

Device Class : 1

Duns Number: 117225590

Premarket Exempt : No

Product Code : JIN

Prescription Use : No

Device Count : 1

KETOCOACH METER ONLY - 00860060002341 Catalog Number :

Device Class : 1

Duns Number: 117225590

Premarket Exempt : No

Product Code : JIN

Prescription Use : No

Device Count : 1

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