Superline

GUDID 08809220580031

Superline is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It is inserted in the subcutaneous tissue and Not intended for use into blood vessel.

SOOIL DEVELOPMENT CO.,LTD

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• Primary Device ID: 08809220580031
• NIH Device Record Key: f6431977-93e6-4958-b5a2-68edf1835103
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Superline
• Version Model Number: SU101
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	08809220580031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022317

FDA Product Code

• LZG: Pump, Infusion, Insulin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-22
• Device Publish Date: 2023-06-14

On-Brand Devices [Superline]

• 08809220580048: Superline is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It
• 08809220580031: Superline is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It
• 08809220580017: Superline is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It
• 18809220580434: Superline is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It