twiist
GUDID 00850017421431
twiist Disposable Cassette Pack (Sterile)
SEQUEL MED TECH, LLC
Ambulatory insulin infusion pump/interstitial glucose monitoring system| Primary Device ID | 00850017421431 |
| NIH Device Record Key | acf09e61-9fe0-4aab-8998-27bb964a82a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | twiist |
| Version Model Number | DKPI-11099-001 |
| Company DUNS | 119070341 |
| Company Name | SEQUEL MED TECH, LLC |
| Device Count | 10 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850017421431 [Unit of Use] |
| GS1 | 00850017421448 [Primary] |
FDA Product Code
| QJI | Interoperable Automated Glycemic Controller |
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 | 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 |
| 00850017421479 | twiist Replacement Pump Kit |
Trademark Results [twiist]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TWIIST 97979283 not registered Live/Pending |
DEKA Research & Development Corp. 2023-02-27 |
 TWIIST 97979282 not registered Live/Pending |
DEKA Research & Development Corp. 2023-02-27 |
 TWIIST 97812897 not registered Live/Pending |
DEKA Research & Development Corp. 2023-02-27 |
 TWIIST 97812874 not registered Live/Pending |
DEKA Research & Development Corp. 2023-02-27 |
 TWIIST 79354199 not registered Live/Pending |
GEFRAN S.P.A. 2022-06-07 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.