Identity
- Trade Name
- MODD1 Supply Kit FDA UDI
- Generic Name
- Ambulatory insulin infusion administration set/reservoir kit FDA UDI
- Device Name
- Kit containing ten (10) of each of the following: Insulin Cartridges, Infusion Sets, Adhesive Pads, Needles, and Syringes. FDA UDI
- Model / Reference
- MODD1 Insulin Delivery System FDA UDI
- Description
- Kit containing ten (10) of each of the following: Insulin Cartridges, Infusion Sets, Adhesive Pads, Needles, and Syringes. FDA UDI
Identifiers
- Catalog Number
- MTL-64 FDA UDI
- Primary DI / UDI-DI
- 00850037806065 FDA UDI
- 510(k) Number
- K240158 FDA UDI
- FDA Product Code
- LZG FDA UDI
- GMDN Term
- Ambulatory insulin infusion administration set/reservoir kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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: Ambulatory insulin infusion administration set/reservoir kit
MODD1 Supply Kit by Modular Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ambulatory insulin infusion administration set/reservoir kit.
- MODD1 Adhesive Pad, 10 Pack — Modular Medical, Inc. · Class II
Cleared under the same submission
K240158 also covers:
- MMI App for iOS — Modular Medical, Inc.
- MODD1 Adhesive Pad, 10 Pack — Modular Medical, Inc.
- MODD1 Infusion Set, 10 Pack — Modular Medical, Inc.
- MODD1 Insulin Cartridge, 10 Pack — Modular Medical, Inc.
- MODD1 Patient Welcome Kit — Modular Medical, Inc.
- MODD1 Pump — Modular Medical, Inc.
- MODD1 Starter Kit — Modular Medical, 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
- Modular Medical, Inc.
Sources (1)
- FDA UDI 1abe94f7-e9d4-448b-a990-bd9806ab9c8b 37 fields · synced May 30, 2026