PRECICHEK AutoCode vial packed test strip 3S-01-16003F

GUDID 04260236851234

PRECICHEK AutoCode Blood Glucose ACH vial packed test strip.

HMD BIOMEDICAL INC.

Glucose IVD, kit, electrometry

Primary Device ID	04260236851234
NIH Device Record Key	8c78d28e-1e0a-4e6a-8617-dffc0c0c141a
Commercial Distribution Status	In Commercial Distribution
Brand Name	PRECICHEK AutoCode vial packed test strip
Version Model Number	3S-01-16003F
Catalog Number	3S-01-16003F
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	04260236850916 [Primary]
GS1	04260236851234 [Package] Contains: 04260236850916 Package: BOX [200 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

On-Brand Devices [PRECICHEK AutoCode vial packed test strip]

04260236851241	PRECICHEK AutoCode Blood Glucose ACH vial packed test strip.
04260236851234	PRECICHEK AutoCode Blood Glucose ACH vial packed test strip.