Dagamma

GUDID 00628055787440

The Dagamma DP200 finger pulse oximeter is a lightweight, portable device used for measuring both heart rate and blood oxygen levels or SpO2 and Perfusion Index.

DAGAMMA INC.

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• Primary Device ID: 00628055787440
• NIH Device Record Key: 0f561936-582e-429a-804b-39ef9c208188
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dagamma
• Version Model Number: Finger Pulse Oximeter DP200
• Company DUNS: 080572190
• Company Name: DAGAMMA 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055787440 [Primary]
GS1	10628055787447 [Package]; Package: Product Package [1 Units]; In Commercial Distribution
GS1	20628055787444 [Package]; Contains: 10628055787447; Package: Master Carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191430

FDA Product Code

• DQA: Oximeter

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: 2021-11-10
• Device Publish Date: 2020-05-28

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• 00628055787440: The Dagamma DP200 finger pulse oximeter is a lightweight, portable device used for measuring bot