Sage

GUDID 06944414038966

Shenzhen Med-link Electronics Tech Co.,LTD

Pulse oximeter probe, single-use

• Primary Device ID: 06944414038966
• NIH Device Record Key: 97bf8218-63b2-4f81-8a87-78e59d05c129
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sage
• Version Model Number: DP060X-09M
• Company DUNS: 527221129
• Company Name: Shenzhen Med-link Electronics Tech Co.,LTD
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944414038966 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113727

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: 2020-03-27
• Device Publish Date: 2018-08-29

On-Brand Devices [Sage]

• 06944414038973: DP07X-09M
• 06944414038966: DP060X-09M
• 06944414040150: DP062X-09M