TotalVitals GMDTVSBPO2T

GUDID B377GMDTVSBPO2T0

GLOBALMEDIA GROUP, LLC

Multiple physiological parameter spot-check analysis system, clinical

• Primary Device ID: B377GMDTVSBPO2T0
• NIH Device Record Key: 779374fb-2186-4d49-b090-38b743b52eb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TotalVitals
• Version Model Number: N/A
• Catalog Number: GMDTVSBPO2T
• Company DUNS: 103201849
• Company Name: GLOBALMEDIA GROUP, LLC
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B377GMDTVSBPO2T0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123711

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-24

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