Adview 2® 9005SPDPS

GUDID 00634782595456

Adview2 SpO2 Pediatric Sensor,20 Ped Sensors w/9' Cable

AMERICAN DIAGNOSTIC CORP

Automatic-inflation electronic sphygmomanometer, non-portable Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 00634782595456
• NIH Device Record Key: a5a73075-6531-4d52-865d-623fe931e45f
• Commercial Distribution Discontinuation: 2019-04-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Adview 2®
• Version Model Number: 9005SPDPS
• Catalog Number: 9005SPDPS
• Company DUNS: 108999095
• Company Name: AMERICAN DIAGNOSTIC CORP
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634782094010 [Primary]
GS1	00634782595456 [Package]; Contains: 00634782094010; Package: Master Case [8 Units]; Discontinued: 2019-04-19; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160439

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-05-11

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