QardioArm A100-ILR

GUDID 00854894005036

QARDIO, INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00854894005036
• NIH Device Record Key: d09c0f63-2860-4f86-837f-39b34cd9a4b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QardioArm
• Version Model Number: A100
• Catalog Number: A100-ILR
• Company DUNS: 080029958
• Company Name: QARDIO, 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: false
• Lot Batch: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854894005036 [Primary]
GS1	10854894005033 [Package]; Package: Masterbox [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140067

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: 2016-09-24

On-Brand Devices [QardioArm]

• 00854894005210: A100
• 00854894005203: A100
• 00854894005135: A100
• 00854894005111: A100
• 00854894005104: A100
• 00854894005081: A100
• 00854894005074: A100
• 00854894005067: A100
• 00854894005050: A100
• 00854894005043: A100
• 00854894005036: A100
• 00854894005029: A100
• 00854894005012: A100
• 00854894005005: A100