PACIFIC MEDICAL

GUDID 06944414039642

Shenzhen Med-link Electronics Tech Co.,LTD

Pulse oximeter probe, reusable

• Primary Device ID: 06944414039642
• NIH Device Record Key: cb63cfd7-2c21-4f15-b7a3-38c7bbc50e74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACIFIC MEDICAL
• Version Model Number: S0044D-S
• 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: false
• 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	06944414039642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083010

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: 2019-05-23

Devices Manufactured by Shenzhen Med-link Electronics Tech Co.,LTD

• 06944414007405 - MED-LINK: 2024-06-06
• 06944414009829 - MED-LINK: 2024-06-06
• 06944414011617 - MED-LINK: 2024-06-06
• 06944414014489 - MED-LINK: 2024-06-06
• 06944414049955 - MED-LINK: 2024-06-06
• 06944414072052 - MED-LINK: 2024-03-21
• 06944414072182 - MED-LINK: 2024-03-21
• 06944414072199 - MED-LINK: 2024-03-21