Identity
- Trade Name
- Tandem t:slimTruSteel Kit FDA UDI
- Generic Name
- Ambulatory insulin infusion pump reservoir FDA UDI
- Device Name
- Tandem t:slim TRUSTL PK10 23" FDA UDI
- Model / Reference
- 1017101 FDA UDI
- Description
- Tandem t:slim TRUSTL PK10 23" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00389152710174 FDA UDI
- FDA Product Code
- QFG FDA UDIQJI FDA UDI
- GMDN Term
- Ambulatory insulin infusion pump reservoir FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5730 FDA UDI862.1356 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electric infusion pump administration set, single-useAmbulatory insulin infusion pump, electronic, software-dosing, scalar algorithmAmbulatory insulin infusion pump reservoir
Tandem t:slimTruSteel Kit by Tandem Diabetes Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ambulatory insulin infusion pump reservoir.
- iLet Insulin Infusion Kit - Inset (23”, 6mm) 15-Pack (Pharmacy Kit) — Beta Bionics, Inc. · Class II
- MiniMed Reservoir — MEDTRONIC MINIMED, INC. · Class II
- MiniMed™ Reservoir — MEDTRONIC MINIMED, INC. · Class III
- DANA Diabecare — SOOIL DEVELOPMENT CO., LTD · Class II
- iLet Insulin Infusion Kit - Inset (32”, 6mm) 15-Pack (Pharmacy Kit) — Beta Bionics, Inc. · Class II
- iLet Starter Kit - Contact Detach — Beta Bionics, Inc. · Class II
- CeQur Simplicity — Cequr SA · Class II
- iLet Insulin Infusion Kit – Contact Detach™ (23"", 6mm) - 20-Pack — Beta Bionics, Inc. · Class II
Cleared under the same submission
K232380 also covers:
- Pharmacy Kit, Starter Pack, Tandem T:slim — Tandem Diabetes Care, Inc.
- Tandem t:slim AutoSoft XC Kit — Tandem Diabetes Care, Inc.
- Tandem t:slim AutoSoft XC Kit — Tandem Diabetes Care, Inc.
- Tandem t:slim Autosoft 30 kit — Tandem Diabetes Care, Inc.
- Tandem t:slim Autosoft 30 kit — Tandem Diabetes Care, Inc.
- Tandem t:slim Mobile Application, Android — Tandem Diabetes Care, Inc.
- t:slim Mobile Application, iOS — Tandem Diabetes Care, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tandem Diabetes Care, Inc.
Sources (1)
- FDA UDI 51a60470-9a85-425c-b5cc-1abf2e76ee08 34 fields · synced Jun 8, 2026