Omnipod 5 Controller SKT-H001-G-X9

GUDID 10385083000022

Omnipod 5 Controller (PDM) mg/dl - English with PodPals

INSULET CORPORATION

Ambulatory insulin infusion pump/interstitial glucose monitoring system

Primary Device ID	10385083000022
NIH Device Record Key	d044bf69-33ef-48de-bb48-ea2edce1eac6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Omnipod 5 Controller
Version Model Number	PDM-H001-G-XX
Catalog Number	SKT-H001-G-X9
Company DUNS	051334402
Company Name	INSULET CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com
Phone	978-600-7155
Email	RA@insulet.com

Operating and Storage Conditions

Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	10385083000022 [Primary]
GS1	30385083000019 [Package] Package: Starter Kit w/ Pals [1 Units] In Commercial Distribution
GS1	30385083000095 [Package] Package: Starter Kit w/o Pals [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K203768

FDA Product Code

QFG	Alternate Controller Enabled Insulin Infusion Pump

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-03-07
Device Publish Date	2022-02-25

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