Welch Allyn SPO2 Sensor Not Applicable

GUDID 00816703026991

SPO2 Sensor for Welch Allyn Propaq LT

MEDSOURCE INTERNATIONAL LLC

Pulse oximeter probe, reprocessed

• Primary Device ID: 00816703026991
• NIH Device Record Key: 9901ddd8-0978-4617-b1e9-d9fbe4fce98f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Welch Allyn SPO2 Sensor
• Version Model Number: MS-WADEC4
• Catalog Number: Not Applicable
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
GS1	00816703026991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082787

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: 2021-08-24
• Device Publish Date: 2021-08-16

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