E-Sphyg™ II 9002-4

GUDID 00634782857660

Battery Pack Cover ONLY-9002,

AMERICAN DIAGNOSTIC CORP

Blood pressure cuff, reusable

• Primary Device ID: 00634782857660
• NIH Device Record Key: 16c468fc-7640-4ec8-a962-c7a95692e627
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-Sphyg™ II
• Version Model Number: 9002-4
• Catalog Number: 9002-4
• 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: false
• 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: 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 Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634782057886 [Primary]
GS1	00634782857660 [Package]; Contains: 00634782057886; Package: Inner Pack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061086

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: 2019-07-22
• Device Publish Date: 2016-09-21

On-Brand Devices [E-Sphyg™ II]

• 00634782595654: DIAGNOSTIX e-sphyg 2,Multicuff, Standard, LF
• 00634782083366: AC Adapter-9002,United Kingdom
• 00634782062965: DIAGNOSTIX e-sphyg 2 Digital,WIP
• 00634782059774: AC Adapter-9002,European
• 00634782057909: Mounting Plate-9002,w/hardware
• 00634782057893: Battery Pack-9002,Rechargeable, 1/ea.
• 00634782857660: Battery Pack Cover ONLY-9002,
• 00634782064983: AC Adapter-9002,American
• 00634782857646: Connector for 9002
• 00634782057855: Cuff Storage Base-9002,Desktop Stand, Black