DEVICE: Omnipod (10385081120005)

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Device Record History
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Device Identifier (DI) Information
Omnipod
ZXP420
In Commercial Distribution
14000
Insulet Corporation
10385081120005
GS1

1
051334402 *Terms of Use
Eros Pod Insulin pump.
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Device Characteristics
MR Unsafe
No
No
Yes
Yes
No
No
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
LZG Pump, Infusion, Insulin
NBW System, Test, Blood Glucose, Over The Counter
NDC Calculator, Drug Dose
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 2 Milliliter
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Device Record Status
71af660f-a114-4d32-8746-279ef498d3e3
July 29, 2024
6
September 24, 2016
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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
20385081120002 10 10385081120005 In Commercial Distribution Box
20385081120101 10 10385081120005 2018-12-15 Not in Commercial Distribution Box
20385081120057 5 10385081120005 In Commercial Distribution Box
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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
Yes
Yes
No CLOSE

Customer Contact

[?]
800-591-3455
xxxx@xxx.com
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