QardioBase B100-IOW

GUDID 00854894005173

QARDIO, INC.

Bioelectrical body composition analyser

• Primary Device ID: 00854894005173
• NIH Device Record Key: 972ce8f0-032e-4232-94b5-ead3a198b695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QardioBase
• Version Model Number: B100
• Catalog Number: B100-IOW
• Company DUNS: 080029958
• Company Name: QARDIO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00854894005173 [Primary]
GS1	10854894005170 [Package]; Package: Masterbox [4 Units]; In Commercial Distribution

FDA Product Code

• MNW: Analyzer, Body Composition

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by QARDIO, INC.

• 10854894005347 - QardioArm2: 2023-06-27
• 10854894005354 - QardioArm2: 2023-06-27
• 10854894005392 - Qardio Pro Cellular Blood Pressure Monitor: 2021-12-07 Pro Cellular Blood Pressure Monitor
• 10854894005415 - Qardio Pulse Oximeter: 2021-01-21
• 10854894005422 - Qardio Forehead thermometer: 2021-01-18
• 00854894005005 - QardioArm: 2019-11-08
• 00854894005012 - QardioArm: 2019-11-08
• 00854894005029 - QardioArm: 2019-11-08