i-STAT 03P75-61

GUDID 00054749003822

i-Stat 1 Wireless Analyzer

ABBOTT POINT OF CARE INC.

Metabolic profile clinical chemistry analyser IVD, portable, semi-automated

• Primary Device ID: 00054749003822
• NIH Device Record Key: 4599ac91-cf41-44b1-8460-e57f4550b2bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-STAT
• Version Model Number: 03P75-61
• Catalog Number: 03P75-61
• Company DUNS: 079226216
• Company Name: ABBOTT POINT OF CARE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com
• Phone: +1(800)366-8020
• Email: techsvc@apoc.abbott.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 40000 KiloPascal and 113324 KiloPascal
• Handling Environment Atmospheric Pressure: Between 40000 KiloPascal and 113324 KiloPascal
• Handling Environment Atmospheric Pressure: Between 40000 KiloPascal and 113324 KiloPascal
• Handling Environment Atmospheric Pressure: Between 40000 KiloPascal and 113324 KiloPascal
• Handling Environment Atmospheric Pressure: Between 40000 KiloPascal and 113324 KiloPascal
• Handling Environment Atmospheric Pressure: Between 40000 KiloPascal and 113324 KiloPascal
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 46 Degrees Celsius
• Storage Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00054749003822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103195

FDA Product Code

• CGA: GLUCOSE OXIDASE, GLUCOSE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-09

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