FDA.reportPublic FDA data

MODD1 Infusion Set, 10 Pack

Primary DI
10850037806048
Brand
MODD1 Infusion Set, 10 Pack
Company
Modular Medical, Inc.
Model
MODD1 Insulin Delivery System
Catalog number
MTL-67
Device description
Box of ten (10) MODD1 Infusion Sets
Published
2025-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZGPump, Infusion, Insulin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZGPump, Infusion, InsulinGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240158000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240158000Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.2024-09-04LZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850037806041PrimaryGS10
10850037806048Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037806041008500378060418500378060410850037806041
1085003780604810850037806048

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
602638525
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850037806089PIVOT Supply Kit (5pk)Pivot Insulin Delivery SystemMTL-2982026-05-18
00850037806140PIVOT Insulin Pump Starter KitPivot Insulin Delivery SystemMTL-2962026-05-18
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
00850037806096MODD1 PumpMODD1 Insulin Delivery SystemMTL-542025-07-11
00850037806119MODD1 Starter KitMODD1 Insulin Delivery SystemMTL-682025-07-11
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
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
10385082000009Omnipod DASH PDMInsulet CorporationLZG2025-08-25
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
00850037806065MODD1 Supply KitModular Medical, Inc.LZG2025-07-11
00850037806102MODD1 PumpModular Medical, Inc.LZG2025-07-11
00850037806119MODD1 Starter KitModular Medical, Inc.LZG2025-07-11
00850037806126MODD1 Patient Welcome KitModular Medical, Inc.LZG2025-07-11
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