Twiist
twiist Convenience Starter Kit with Cleo Infusion Set
1manufacturer
8catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
Record
| Listed by | Sequel MED Tech, LLC |
|---|---|
| FDA product code | QJI |
| Device type | Interoperable Automated Glycemic Controller |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1356 |
| Record published | 2025-04-10 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DKPI-11073-001 | In distribution | ||
| CM-10100 | In distribution | ||
| DKPI-11029-007 | In distribution | ||
| DKPI-11099-001 | 10 | In distribution | |
| DKPI-21073-007 | In distribution | ||
| RF-90400 | In distribution | ||
| DKPI-11098-001 | In distribution | ||
| RF-90100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| iLet Bionic Pancreas | Beta Bionics, Inc. | 6 |
| Tandem t:slim Autosoft 30 Kit | Tandem Diabetes Care, Inc. | 4 |
| Tandem t:slim Autosoft XC Kit | Tandem Diabetes Care, Inc. | 2 |
| iLet Starter Kit – Inset 23″ | Beta Bionics, Inc. | 1 |
| iLet Starter Kit | Beta Bionics, Inc. | 1 |
| t:slim X2 Insulin Pump with Control-IQ | Tandem Diabetes Care, Inc. | 1 |
| iLet Starter Kit – Contact Detach | Beta Bionics, Inc. | 1 |
| Tandem t:slimTruSteel Kit | Tandem Diabetes Care, Inc. | 1 |
| iLet Starter Kit – Inset 32″ | Beta Bionics, Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.