Insulia

GUDID 03760261310061

VOLUNTIS

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• Primary Device ID: 03760261310061
• NIH Device Record Key: 1384c710-9146-4adf-80b9-88f5b406b4af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insulia
• Version Model Number: Redwing W_1.6_US
• Company DUNS: 572684194
• Company Name: VOLUNTIS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760261310061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172177

FDA Product Code

• NDC: Calculator, Drug Dose

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: 2019-05-07
• Device Publish Date: 2018-08-21

On-Brand Devices [Insulia]

• 03760261310085: Redwing A_1.6_US
• 03760261310078: Redwing I_1.6_US
• 03760261310061: Redwing W_1.6_US
• 03760261310023: Redwing 1AUS
• 03760261310016: REdwing 1IUS
• 03760261310009: Redwing 1WUS