Medke

GUDID 06971018115328

Shenzhen MedKe Technology Co., Ltd

Pulse oximeter probe, reusable

• Primary Device ID: 06971018115328
• NIH Device Record Key: 7f122dc4-0c37-4e21-be0b-9c30fe0e93c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medke
• Version Model Number: P11019-01
• 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	06971018115328 [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