Omnipod PodPals

GUDID 10385081120234

Omnipod Adhesive Overlay (Podpals)

INSULET CORPORATION

Ambulatory insulin infusion pump/blood glucose analyser system

• Primary Device ID: 10385081120234
• NIH Device Record Key: 61723978-b4b6-4b35-a50c-948c8e70b9fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnipod PodPals
• Version Model Number: POD-X9-990
• Company DUNS: 051334402
• Company Name: INSULET CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	10385081120234 [Primary]
GS1	20385081120231 [Package]; Package: Box Adhesive Pads [10 Units]; In Commercial Distribution
GS1	20385083000104 [Package]; Package: Box Adhesive Pads [3 Units]; In Commercial Distribution

FDA Product Code

• KGX: Tape And Bandage, Adhesive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-09
• Device Publish Date: 2019-07-01

Devices Manufactured by INSULET CORPORATION

• 10385083000336 - Omnipod 5 Controller APP: 2024-07-30 Omnipod 5 Controller APP
• 20385081120019 - Omnipod: 2024-07-29 Eros PDM (Personal Diabetes Manager)
• 10385081140003 - Omnipod: 2024-07-29 Eros PDM(Personal Diabetes Manager)
• 20385082000020 - Omnipod DASH Pod: 2024-07-29 DASH Pod
• 10385083000503 - Omnipod 5 Starter Kit: 2024-07-29 Omnipod 5 Starter Kit mg/dl
• 10385083000565 - Omnipod 5 Controller APP: 2024-07-29 Omnipod 5 Controller APP
• 20385083000531 - Omnipod 5 Pod: 2024-05-13 Omnipod 5 Pod
• 20385084000103 - Omnipod Go Insulin Delivery Device 10U/day POD: 2023-08-28 Omnipod Go Insulin Delivery Device 10U/day POD