- Physicians Office Resource

Omnipod DASH Personal Diabetes Manager (PDM) mg/dL
Omnipod DASH PDM - PDM-USA1-D001-MG-USA1

Device Description

An assembly of devices intended to provide remotely-controlled basal and/or periodic bolus subcutaneous delivery of insulin to a patient with diabetes mellitus. It consists of a badge-like, battery-powered, disposable device (electromechanical pumping unit, an insulin reservoir filled by the patient, and an administration cannula/needle) designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), and a wireless unit with dedicated software that interfaces with the pump to control and program pump functions and receive pump status information. The remote control may be capable of data transmission to other platforms.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NBW

Device Name: System, Test, Blood Glucose, Over The Counter

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1345

Third Party Flag: N

Medical Specialty: CH

Code: LZG

Device Name: Pump, Infusion, Insulin

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.5725

Third Party Flag: N

Medical Specialty: HO

Code: NDC

Device Name: Calculator, Drug Dose

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 868.1890

Third Party Flag: N

Medical Specialty: AN

Device Identifiers

Device Id: 10385082000009

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 10385082000542

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10385082000009

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Kit

Device Id: 10385081140010

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10385082000009

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Pharmacy Kit

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