FDA.reportPublic FDA data

Pivot App for iOS

Primary DI
00850037806164
Brand
Pivot App for iOS
Company
Modular Medical, Inc.
Model
Pivot Insulin Delivery System
Catalog number
SW-33
Device description
iOS smartphone application for Pivot Insulin Delivery System, software version v2.X
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K253534000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253534000Pivot Insulin Delivery SystemModular Medical2026-04-08LZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850037806164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037806164008500378061648500378061640850037806164

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump software, patient-dosingA software application intended to allow a patient to remotely control the functions of an electronic ambulatory insulin infusion pump or pump/administration unit (e.g., pharmaceutical delivery, dosage settings), and typically also extract data from the pump. It is intended to be used on a non-medical computerized device (e.g., smartphone) and may transmit data to other platforms for recording/analysis.

Contacts#

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

Regulatory Flags#

DUNS number
602638525
Device count
1
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
false
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
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
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
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
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
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
10850037806048MODD1 Infusion Set, 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
10385084000106Omnipod Go Insulin Delivery Device 10U/day PODInsulet CorporationLZG2023-08-18
10385084000151Omnipod Go Insulin Delivery Device 15U/dayInsulet CorporationLZG2023-08-18
10385084000205Omnipod Go Insulin Delivery Device 20U/dayInsulet CorporationLZG2023-08-18
10385084000250Omnipod Go Insulin Delivery Device 25U/dayInsulet CorporationLZG2023-08-18
10385084000304Omnipod Go Insulin Delivery Device 30U/dayInsulet CorporationLZG2023-08-18
10385084000359Omnipod Go Insulin Delivery Device 35U/dayInsulet CorporationLZG2023-08-18
10385084000403Omnipod Go Insulin Delivery Device 40U/dayInsulet CorporationLZG2023-08-18
20385084000103Omnipod Go Insulin Delivery Device 10U/day PODINSULET CORPORATIONLZG2023-08-18
20385084000158Omnipod Go Insulin Delivery Device 15U/dayINSULET CORPORATIONLZG2023-08-18
20385084000202Omnipod Go Insulin Delivery Device 20U/dayINSULET CORPORATIONLZG2023-08-18
20385084000257Omnipod Go Insulin Delivery Device 25U/dayINSULET CORPORATIONLZG2023-08-18
20385084000301Omnipod Go Insulin Delivery Device 30U/dayINSULET CORPORATIONLZG2023-08-18