PRECICHEK AutoCode foil packed test strip 3L-10-16003D

GUDID 04260236851203

PRECICHEK AutoCode Blood Glucose ACH foil packed test strip

HMD BIOMEDICAL INC.

Glucose IVD, kit, electrometry

Primary Device ID	04260236851203
NIH Device Record Key	d2e1d562-6e78-4514-ad1a-86cafa8511b0
Commercial Distribution Status	In Commercial Distribution
Brand Name	PRECICHEK AutoCode foil packed test strip
Version Model Number	3L-10-16003D
Catalog Number	3L-10-16003D
Company DUNS	658644174
Company Name	HMD BIOMEDICAL INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Operating and Storage Conditions

Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260236850664 [Primary]
GS1	04260236851203 [Package] Contains: 04260236850664 Package: FOIL [210 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K120064

FDA Product Code

JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-07-14
Device Publish Date	2020-07-06

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04260236851203	PRECICHEK AutoCode Blood Glucose ACH foil packed test strip