STAT-Site WB B-Ketone Test Strips 7020-050

GUDID 00657498002247

The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary and venous whole blood samples. It should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.

STANBIO LABORATORY, L.P.

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• Primary Device ID: 00657498002247
• NIH Device Record Key: f24035d5-0a6c-47a5-9d65-350194492714
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAT-Site WB B-Ketone Test Strips
• Version Model Number: 7020-050
• Catalog Number: 7020-050
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• Device Count: 50
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com
• Phone: 18005315535
• Email: techsupport@ekfdiagnostics.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498002223 [Unit of Use]
GS1	00657498002247 [Primary]

FDA Product Code

• JIN: Nitroprusside, Ketones (Urinary, Non-Quant.)

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: 2019-11-26
• Device Publish Date: 2019-11-18

On-Brand Devices [STAT-Site WB B-Ketone Test Strips]

• 00657498002254: The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostic
• 00657498002247: The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostic
• 00657498002230: The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostic