DANA Diabecare

GUDID 08809220584862

DANA Diabecare IIS is external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump is not intended for use with blood or blood products.

SOOIL DEVELOPMENT CO.,LTD

Ambulatory insulin infusion pump, electronic, non-software-dosing

• Primary Device ID: 08809220584862
• NIH Device Record Key: fccc6e65-338e-4a66-90d8-b04b2454aef1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DANA Diabecare
• Version Model Number: II
• Company DUNS: 688006266
• Company Name: SOOIL DEVELOPMENT 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: 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	08809220584862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063126

FDA Product Code

• LZG: Pump, Infusion, Insulin

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: 2023-06-19
• Device Publish Date: 2023-06-09

On-Brand Devices [DANA Diabecare]

• 08809220584862: DANA Diabecare IIS is external programmable syringe infusion pump used for the subcutaneous deli
• 08809220584855: DANA Diabecare is external programmable syringe infusion pump used for the subcutaneous delivery