Panasonic

GUDID 00851439007029

Portable Automatic Arm Blood Pressure Monitor

PANASONIC CORPORATION OF NORTH AMERICA

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00851439007029
• NIH Device Record Key: 08ce9f55-9cca-4576-ba02-7ad1cb74f811
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panasonic
• Version Model Number: EW3109
• Company DUNS: 008919813
• Company Name: PANASONIC CORPORATION OF NORTH AMERICA
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851439007029 [Primary]
GS1	10851439007026 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991458

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: 2016-11-25

On-Brand Devices [Panasonic]

• 10851439007088: Large Cuff for Panasonic Arm Blood Pressure Monitor
• 00851439007029: Portable Automatic Arm Blood Pressure Monitor
• 00851439007050: EW-DJ10-W551
• 00851439007043: EW1213A351
• 00851439007036: EW1511W551
• 00851439007012: EW1611W551
• 00851439007098: ER-CTB1-A
• 00851439007074: Oral Irrigator