twiist

GUDID 00850017421400

twiist Pump Assembly, Labeled

SEQUEL MED TECH, LLC

Ambulatory insulin infusion pump/interstitial glucose monitoring system

• Primary Device ID: 00850017421400
• NIH Device Record Key: 1da7e1b8-9080-46d2-bb22-d680ed39f370
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: twiist
• Version Model Number: DKPI-21073-007
• Company DUNS: 119070341
• Company Name: SEQUEL MED TECH, LLC
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-489-4478
• Email: support@sequelmedtech.com
• Phone: 877-489-4478
• Email: support@sequelmedtech.com
• Phone: 877-489-4478
• Email: support@sequelmedtech.com
• Phone: 877-489-4478
• Email: support@sequelmedtech.com
• Phone: 877-489-4478
• Email: support@sequelmedtech.com
• Phone: 877-489-4478
• Email: support@sequelmedtech.com
• Phone: 877-489-4478
• Email: support@sequelmedtech.com
• Phone: 877-489-4478
• Email: support@sequelmedtech.com
• Phone: 877-489-4478
• Email: support@sequelmedtech.com
• Phone: 877-489-4478
• Email: support@sequelmedtech.com
• Phone: 877-489-4478
• Email: support@sequelmedtech.com
• Phone: 877-489-4478
• Email: support@sequelmedtech.com
• Phone: 877-489-4478
• Email: support@sequelmedtech.com
• Phone: 877-489-4478
• Email: support@sequelmedtech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017421400 [Primary]

FDA Product Code

• QJI: Interoperable Automated Glycemic Controller

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: 2025-04-18
• Device Publish Date: 2025-04-10

On-Brand Devices [twiist]

• 00198617904009: twiist Refill Kit without Infusion Set
• 00198617901008: twiist Refill Kit with Cleo Infusion Set
• 00198617101002: twiist Convenience Starter Kit with Cleo Infusion Set
• 00850017421431: twiist Disposable Cassette Pack (Sterile)
• 00850017421424: twiist Pump Starter Kit
• 00850017421400: twiist Pump Assembly, Labeled