S.G. Calibrator H N/A

GUDID 04987486053002

The S.G. Calibrator H is used for calibration of the S.G. measurement system of the AUTION system. The S.G. Calibrator establishes reference points based on the physical principles of AUTION analyzers.

ARKRAY USA, INC.

Urine analyser IVD, laboratory

• Primary Device ID: 04987486053002
• NIH Device Record Key: 01bf9878-2c4c-4973-b0d1-a06212ab1bfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S.G. Calibrator H
• Version Model Number: 111581
• Catalog Number: N/A
• Company DUNS: 008171162
• Company Name: ARKRAY USA, 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: 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: 855-646-3108
• Email: xx@xx.xx
• Phone: 855-646-3108
• Email: xx@xx.xx
• Phone: 855-646-3108
• Email: xx@xx.xx
• Phone: 855-646-3108
• Email: xx@xx.xx
• Phone: 855-646-3108
• Email: xx@xx.xx
• Phone: 855-646-3108
• Email: xx@xx.xx
• Phone: 855-646-3108
• Email: xx@xx.xx
• Phone: 855-646-3108
• Email: xx@xx.xx
• Phone: 855-646-3108
• Email: xx@xx.xx
• Phone: 855-646-3108
• Email: xx@xx.xx
• Phone: 855-646-3108
• Email: xx@xx.xx
• Phone: 855-646-3108
• Email: xx@xx.xx
• Phone: 855-646-3108
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a refrigerator, avoiding exposure to light.
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a refrigerator, avoiding exposure to light.
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a refrigerator, avoiding exposure to light.
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a refrigerator, avoiding exposure to light.
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a refrigerator, avoiding exposure to light.
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a refrigerator, avoiding exposure to light.
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a refrigerator, avoiding exposure to light.
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a refrigerator, avoiding exposure to light.
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a refrigerator, avoiding exposure to light.
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a refrigerator, avoiding exposure to light.
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a refrigerator, avoiding exposure to light.
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a refrigerator, avoiding exposure to light.
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a refrigerator, avoiding exposure to light.
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987486053002 [Primary]

FDA Product Code

• JMT: Diazo (Colorimetric), Nitrite (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: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [S.G. Calibrator H]

• 04987486001959: The S.G. Calibrator H is used to calibrate specific gravity on the AUTION HYBRID AU-4050, AUTION
• 04987486053002: The S.G. Calibrator H is used for calibration of the S.G. measurement system of the AUTION syste