DEVICE: Omnipod DASH Starter Kit (10385082000009)

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Device Record History
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Device Identifier (DI) Information
Omnipod DASH Starter Kit
PDM-USA1-DOO1-MG-USA1
In Commercial Distribution

Insulet Corporation
10385082000009
GS1

1
051334402 *Terms of Use
(PDM) mg/dL - DASH, English
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Device Characteristics
MR Unsafe
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
51083 Ambulatory insulin infusion pump/blood glucose analyser system
An assembly of battery-powered portable devices designed to deliver insulin and to measure blood glucose as an aid in the management of diabetes mellitus for a patient requiring insulin. It consists of a portable electronic insulin pump that provides continuous subcutaneous delivery of insulin at set and variable rates, and a wireless microprocessor remote controller that interfaces with the pump to control pump functions and receive pump status information. The controller also incorporates a blood glucose meter and built-in test strip port for the quantitative measurement of glucose in fresh capillary blood.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NDC Calculator, Drug Dose
LZG Pump, Infusion, Insulin
QFG Alternate Controller Enabled Insulin Infusion Pump
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 32 and 86 Degrees Fahrenheit
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 700 and 1060 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
68e19fa7-6906-4010-a1e1-be6b440f4a75
May 02, 2025
8
July 03, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20385082000006 1 10385082000009 In Commercial Distribution Starter Kit
30385081140014 1 20385082000006 In Commercial Distribution Welcome Kit
10385082000542 1 10385082000009 In Commercial Distribution Starter Kit
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
9786007155
RA@insulet.com
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