Kit containing one (1) Pump (software version v1.X), Inserter, User Guide, Quick Start Guide, Patient Medical Device Card, and ten (10) of each of the following: Cartridges, Patches,…
Kit containing one (1) Pump (software version v1.X), Inserter, User Guide, Quick Start Guide, Patient Medical Device Card, and ten (10) of each of the following: Cartridges, Patches, Needles, and Syringes.
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.
Record
Regulatory record for Pivot Insulin Pump Starter Kit | 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) | K253534 |
| Record published | 2026-05-18 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 41 to 104 °F; Handling environment humidity 20 to 90 % RH |
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.