FDA UDI
In Commercial Distribution
🇺🇸 United States
MODD1 Pump
DI: 00850037806096
·
Model: MODD1 Insulin Delivery System
·
Modular Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MODD1 Pump
- Primary DI
- 00850037806096
- Version / Model
- MODD1 Insulin Delivery System
- Catalog Number
- MTL-54
- Company Name
- Modular Medical, Inc.
- Labeler DUNS
- 602638525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-11
- Public Version
- 2
- Public Version Date
- 2025-10-17
- Public Version Status
- Update
- Public Device Record Key
- 417a3b16-77d7-4b5a-82df-888df8df2a16
Device Description
Box of one (1) MODD1 Pump, software version v1.X
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZG | Pump, Infusion, Insulin | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64889 | Ambulatory insulin infusion pump, electronic, non-software-dosing | A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus; it does not include insulin dosage determining software. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850037806102 | GS1 | MODD1 Pump Refill | 1 | In Commercial Distribution | |
| Primary | 00850037806096 | GS1 |
Customer Contacts
- Phone
- 8667101200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240158 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit