O2Health fingertip pulse oximeter

GUDID 04713072980748

O2Health fingertip pulse oximeter, model: DB11-

DELBIO INC.

Pulse oximeter, battery-powered

• Primary Device ID: 04713072980748
• NIH Device Record Key: e33e811d-33ec-48e5-890a-1e5492e6972a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O2Health fingertip pulse oximeter
• Version Model Number: DB11-B
• Company DUNS: 656777740
• Company Name: DELBIO 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: false
• 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	04713072980748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122927

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: 2020-04-24
• Device Publish Date: 2020-04-16

On-Brand Devices [O2Health fingertip pulse oximeter]

• 04713072980786: O2Health fingertip pulse oximeter, model name: DB12
• 04713072980748: O2Health fingertip pulse oximeter, model: DB11-