DOPPLEX ACC-VAS-009

GUDID 05051968030351

LARGE ADULT LEFT ARM CUFF

HUNTLEIGH HEALTHCARE LIMITED

Noninvasive ankle brachial pressure index measurement unit

• Primary Device ID: 05051968030351
• NIH Device Record Key: eda1b2ce-d33c-4dfa-93f3-490126a513ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOPPLEX
• Version Model Number: ACC-VAS-009
• Catalog Number: ACC-VAS-009
• Company DUNS: 217207083
• Company Name: HUNTLEIGH HEALTHCARE LIMITED
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: +4402920485885
• Email: sales@huntleigh-diagnostics.co

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051968030351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121108

FDA Product Code

• JOM: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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: 2016-09-12

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• 05051968030498: ADULT LEFT ARM CUFF
• 05051968030481: ADULT RIGHT ANKLE CUFF
• 05051968030474: ADULT RIGHT ARM CUFF
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