GUDID 04582275250404

KONAN MEDICAL, INC.

Cell morphology analyser IVD, manual

• Primary Device ID: 04582275250404
• NIH Device Record Key: d9c54fdb-edac-4cae-8adc-8383b6ed1376
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CD-15
• Company DUNS: 690768619
• Company Name: KONAN MEDICAL, INC.
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• 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	04582275250404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040373

FDA Product Code

• NQE: Microscope, specular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by KONAN MEDICAL, INC.

• 04582275250671 - NA: 2023-10-05
• 04582275250664 - NA: 2022-04-15
• 04582275250657 - NA: 2021-07-05
• 04582275250626 - NA: 2020-04-10
• 04582275250107 - NA: 2020-02-13
• 04582275250428 - NA: 2020-02-07
• 04582275250619 - N/A: 2020-01-21
• 04582275250374 - NA: 2018-07-06