S.G. Calibrator H

GUDID 04987486001959

The S.G. Calibrator H is used to calibrate specific gravity on the AUTION HYBRID AU-4050, AUTION MAX AX-4030 and AUTION MAX AX-4280 Urine Analyzers. 

ARKRAY USA, INC.

Urine analyser IVD, laboratory, automated

• Primary Device ID: 04987486001959
• NIH Device Record Key: fb1202f6-6985-4a4d-9eda-826a28ef36b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S.G. Calibrator H
• Version Model Number: 100672
• Company DUNS: 008171162
• Company Name: ARKRAY USA, 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: false
• 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: false

Customer Support Contacts

• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx
• Phone: 9999999999
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987486001959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013783

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-12

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