FDA.reportPublic FDA data

MODD1 Starter Kit

Primary DI
00850037806119
Brand
MODD1 Starter Kit
Company
Modular Medical, Inc.
Model
MODD1 Insulin Delivery System
Catalog number
MTL-68
Device description
Kit containing one (1) of each of the following: Pump (software version v1.X), Infusion Set Inserter, User Guide, Quick Start Guide, and Patient Medical Device Card.
Published
2025-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZHIntroducer, Syringe Needle
LZGPump, Infusion, Insulin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZHIntroducer, Syringe NeedleGeneral Hospital2
LZGPump, Infusion, InsulinGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163400000
K240158000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163400000Orbit InserterYpsomed AG2017-07-26KZH
K240158000Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.2024-09-04LZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850037806119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037806119008500378061198500378061190850037806119

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump, electronic, non-software-dosingA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8667101200customercare@modular-medical.com

Regulatory Flags#

DUNS number
602638525
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850037806034PIVOT Insulin Pump ReplacementPivot Insulin Delivery SystemMTL-3092026-05-26
00850037806072PIVOT InserterPivot Insulin Delivery SystemMTL-3082026-05-26
00850037806133PIVOT Supply Kit (1pk)Pivot Insulin Delivery SystemMTL-3002026-05-26
00850037806164Pivot App for iOSPivot Insulin Delivery SystemSW-332026-05-26
00850037806089PIVOT Supply Kit (5pk)Pivot Insulin Delivery SystemMTL-2982026-05-18
00850037806140PIVOT Insulin Pump Starter KitPivot Insulin Delivery SystemMTL-2962026-05-18
00850037806096MODD1 PumpMODD1 Insulin Delivery SystemMTL-542025-07-11
00850037806003MODD1 Adhesive Pad, 10 PackMODD1 Insulin Delivery SystemMTL-572025-07-11
00850037806027MODD1 Insulin Cartridge, 10 PackMODD1 Insulin Delivery SystemMTL-342025-07-11
00850037806041MODD1 Infusion Set, 10 PackMODD1 Insulin Delivery SystemMTL-672025-07-11
10850037806000MODD1 Adhesive Pad, 10 PackMODD1 Insulin Delivery SystemMTL-572025-07-11
00850037806010MMI App for iOSMODD1 Insulin Delivery SystemMTL-1032025-07-11
10850037806024MODD1 Insulin Cartridge, 10 PackMODD1 Insulin Delivery SystemMTL-342025-07-11
10850037806048MODD1 Infusion Set, 10 PackMODD1 Insulin Delivery SystemMTL-672025-07-11
00850037806058Orbit InserterMODD1 Insulin Delivery SystemMTL-462025-07-11
00850037806065MODD1 Supply KitMODD1 Insulin Delivery SystemMTL-642025-07-11
00850037806102MODD1 PumpMODD1 Insulin Delivery SystemMTL-542025-07-11
00850037806126MODD1 Patient Welcome KitMODD1 Insulin Delivery SystemMTL-2772025-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850037806034PIVOT Insulin Pump ReplacementModular Medical, Inc.LZG2026-05-26
00850037806072PIVOT InserterModular Medical, Inc.LZG2026-05-26
00850037806133PIVOT Supply Kit (1pk)Modular Medical, Inc.LZG2026-05-26
00850037806164Pivot App for iOSModular Medical, Inc.LZG2026-05-26
00850037806089PIVOT Supply Kit (5pk)Modular Medical, Inc.LZG2026-05-18
00850037806140PIVOT Insulin Pump Starter KitModular Medical, Inc.LZG2026-05-18
B33919800010V-CathNeo Medical Inc.KZH2026-03-27
10385082000009Omnipod DASH PDMInsulet CorporationLZG2025-08-25
05713495000121SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
05713495000138SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
57622436104114Glatopaject ®AEROPHARM GmbHKZH2025-08-19
47622436104100Glatopaject ®AEROPHARM GmbHKZH2025-08-19
00860010587317CoolJect Targeted-Mist 1-3cc Nook Syringe Holder AccessoryVapocoolshot, IncKZH2025-08-01
00850037806003MODD1 Adhesive Pad, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806027MODD1 Insulin Cartridge, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806041MODD1 Infusion Set, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806096MODD1 PumpModular Medical, Inc.LZG2025-07-11
10850037806000MODD1 Adhesive Pad, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806010MMI App for iOSModular Medical, Inc.LZG2025-07-11
10850037806024MODD1 Insulin Cartridge, 10 PackModular Medical, Inc.LZG2025-07-11
10850037806048MODD1 Infusion Set, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806058Orbit InserterModular Medical, Inc.KZH2025-07-11
00850037806065MODD1 Supply KitModular Medical, Inc.LZG2025-07-11
00850037806102MODD1 PumpModular Medical, Inc.LZG2025-07-11
00850037806126MODD1 Patient Welcome KitModular Medical, Inc.LZG2025-07-11
00850037806126MODD1 Patient Welcome KitModular Medical, Inc.KZH2025-07-11
00370095000002GripMate™SUN PHARMACEUTICAL INDUSTRIES, INC.KZH2025-05-12
05714472000004Needle Guide AssistantUnion Medico ApSKZH2025-05-05
B33935290030NeoMagicNeo Medical Inc.KZH2025-01-22
B33935290035NeoMagicNEO MEDICAL INC.KZH2025-01-22