MODD1 Infusion Set, 10 Pack
The MODD1 Infusion Set is the disposable part of the MODD1 Insulin Delivery System that enters the tissue beneath the skin. It provides the patient connection for insulin delivered from the…
The MODD1 Infusion Set is the disposable part of the MODD1 Insulin Delivery System that enters the tissue beneath the skin. It provides the patient connection for insulin delivered from the system’s separate cartridge and programmable pump.
The cartridge’s infusion tubing attaches to the set through a tubing cap. An optional, reusable inserter can place the infusion set into the subcutaneous tissue. The set itself is intended for single use.
Listed Item
Box of ten (10) MODD1 Infusion Sets
Compatible System
The MODD1 system is prescribed for adults aged 18 and older who require insulin for diabetes management. It is compatible with Humalog U-100 insulin.
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (3), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Viant Medical Suzhou EPZ Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Modular Medical, United States |
|---|---|
| FDA product code | LZG |
| Device type | Pump, Infusion, Insulin |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K240158 |
| Record published | 2025-07-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 41 to 104 °F |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MODD1 Insulin Delivery System | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OneTouch Ping | Animas Corp. | 12 |
| Easy Release | Sooil Development Co., Ltd. | 9 |
| V-Go Disposable Insulin Delivery | Mannkind Corporation | 6 |
| Accu-Chek Combo | Roche Diabetes Care, Inc. | 5 |
| Superline | Sooil Development Co., Ltd. | 4 |
| t:slim Cartridge, t:lock, 10 Pack | Tandem Diabetes Care, Inc. | 3 |
| Dana Diabecare | Sooil Development Co., Ltd. | 3 |
| Accu-Chek Spirit Cartridge | Roche Diabetes Care, Inc. | 2 |
| t:slim X2 Insulin Pump | Tandem Diabetes Care, Inc. | 2 |
| Omnipod | Insulet Corporation | 2 |
| Soft-Release-ST | Sooil Development Co., Ltd. | 2 |
| t:slim Insulin Pump, Replacement | Tandem Diabetes Care, Inc. | 1 |
Showing 12 of 53. All products under Pump, Infusion, Insulin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262153 | 2026-09-02 |
| K253534 | 2026-04-08 |
| K240158 | 2024-09-04 |
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.