MODD1 Supply Kit MTL-64

GUDID 00850037806065

Kit containing ten (10) of each of the following: Insulin Cartridges, Infusion Sets, Adhesive Pads, Needles, and Syringes.

Modular Medical, Inc.

Ambulatory insulin infusion administration set/reservoir kit
Primary Device ID00850037806065
NIH Device Record Key1abe94f7-e9d4-448b-a990-bd9806ab9c8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMODD1 Supply Kit
Version Model NumberMODD1 Insulin Delivery System
Catalog NumberMTL-64
Company DUNS602638525
Company NameModular Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8667101200
Emailcustomercare@modular-medical.com
Phone8667101200
Emailcustomercare@modular-medical.com
Phone8667101200
Emailcustomercare@modular-medical.com
Phone8667101200
Emailcustomercare@modular-medical.com
Phone8667101200
Emailcustomercare@modular-medical.com
Phone8667101200
Emailcustomercare@modular-medical.com
Phone8667101200
Emailcustomercare@modular-medical.com
Phone8667101200
Emailcustomercare@modular-medical.com
Phone8667101200
Emailcustomercare@modular-medical.com
Phone8667101200
Emailcustomercare@modular-medical.com
Phone8667101200
Emailcustomercare@modular-medical.com
Phone8667101200
Emailcustomercare@modular-medical.com
Phone8667101200
Emailcustomercare@modular-medical.com
Phone8667101200
Emailcustomercare@modular-medical.com

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850037806065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZGPump, Infusion, Insulin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-21
Device Publish Date2025-07-11

Devices Manufactured by Modular Medical, Inc.

10850037806000 - MODD1 Adhesive Pad, 10 Pack2025-07-21 Box of ten (10) MODD1 Adhesive Pads
00850037806010 - MMI App for iOS2025-07-21 iOS smartphone application for MODD1 Insulin Delivery System, software version v1.X
10850037806024 - MODD1 Insulin Cartridge, 10 Pack2025-07-21 Box of ten (10) MODD1 Insulin Cartridges
10850037806048 - MODD1 Infusion Set, 10 Pack2025-07-21 Box of ten (10) MODD1 Infusion Sets
00850037806058 - Orbit Inserter2025-07-21 Box of one (1) Infusion Set Inserter
00850037806065 - MODD1 Supply Kit2025-07-21Kit containing ten (10) of each of the following: Insulin Cartridges, Infusion Sets, Adhesive Pads, Needles, and Syringes.
00850037806065 - MODD1 Supply Kit2025-07-21 Kit containing ten (10) of each of the following: Insulin Cartridges, Infusion Sets, Adhesive Pads, Needles, and Syringes.
00850037806102 - MODD1 Pump2025-07-21 Box of one (1) MODD1 Pump, software version v1.X
00850037806119 - MODD1 Starter Kit2025-07-21 Kit containing one (1) of each of the following: Pump (software version v1.X), Infusion Set Inserter, User Guide, Quick Start Gu

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