Medke

GUDID 06971018115359

Shenzhen MedKe Technology Co., Ltd

Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable

• Primary Device ID: 06971018115359
• NIH Device Record Key: b4f8f77a-98d8-4602-83aa-4fe4c927ac93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medke
• Version Model Number: P11319-01
• Company DUNS: 529655709
• Company Name: Shenzhen MedKe Technology Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971018115359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152390

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: 2019-12-19
• Device Publish Date: 2019-12-11

On-Brand Devices [Medke]

• 06971018115496: P9119
• 06971018115212: P8119
• 06971018114949: P4110C
• 06971018115229: P1019-01
• 06971018115465: P12419-01
• 06971018115458: P12319-01
• 06971018115441: P12219-01
• 06971018115434: P12119-01
• 06971018115427: P12019-01
• 06971018115410: P11919-01
• 06971018115403: P11819-01
• 06971018115397: P11719-01
• 06971018115380: P11619-01
• 06971018115373: P11519-01
• 06971018115366: P11419-01
• 06971018115359: P11319-01
• 06971018115342: P11219-01
• 06971018115335: P11119-01
• 06971018115328: P11019-01
• 06971018115311: P1919-01
• 06971018115304: P1819-01
• 06971018115298: P1719-01
• 06971018115281: P1619-01
• 06971018115274: P1519-01
• 06971018115267: P1419-01
• 06971018115250: P1319-01
• 06971018115243: P1219-01
• 06971018115236: P1119-01
• 06971018118060: P9318E
• 06971018118046: P8119A
• 06971018117698: P1719-01
• 06971018111030: P9119A
• 06971018110613: P1019-01
• 00192243000104: P1319D-01
• 00192243000098: P1315F-01BC