Qardio Pulse Oximeter JPD-500F

GUDID 10854894005415

QARDIO, INC.

Pulse oximeter, battery-powered

• Primary Device ID: 10854894005415
• NIH Device Record Key: 69c56417-b46b-4bee-b456-ee86b8b9671a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qardio Pulse Oximeter
• Version Model Number: JPD-500F
• Catalog Number: JPD-500F
• 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	00854894005418 [Primary]
GS1	10854894005415 [Package]; Contains: 00854894005418; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170965

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-21
• Device Publish Date: 2021-01-13

Devices Manufactured by QARDIO, INC.

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• 10854894005415 - Qardio Pulse Oximeter: 2021-01-21
• 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