| Primary Device ID | 20385081120330 |
| NIH Device Record Key | 64b4c3e1-5cf1-40b5-af15-1a644e73cdd0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnipod PodPals |
| Version Model Number | POD-X9-990NS |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 800-591-3455 |
| RA@insulet.com | |
| Phone | 800-591-3455 |
| RA@insulet.com | |
| Phone | 800-591-3455 |
| RA@insulet.com | |
| Phone | 800-591-3455 |
| RA@insulet.com | |
| Phone | 800-591-3455 |
| RA@insulet.com | |
| Phone | 800-591-3455 |
| RA@insulet.com | |
| Phone | 800-591-3455 |
| RA@insulet.com | |
| Phone | 800-591-3455 |
| RA@insulet.com | |
| Phone | 800-591-3455 |
| RA@insulet.com | |
| Phone | 800-591-3455 |
| RA@insulet.com | |
| Phone | 800-591-3455 |
| RA@insulet.com | |
| Phone | 800-591-3455 |
| RA@insulet.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10385081120333 [Primary] |
| GS1 | 20385081120330 [Package] Contains: 10385081120333 Package: 10-Pack Box [10 Units] In Commercial Distribution |
| GS1 | 20385081120347 [Package] Contains: 10385081120333 Package: 3-Pack Box [3 Units] In Commercial Distribution |
| KGX | Tape And Bandage, Adhesive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-04 |
| Device Publish Date | 2025-04-16 |
| 10385081120234 | Omnipod Adhesive Overlay (Podpals) |
| 20385081120330 | Omnipod Adhesive Overlay (PodPals) non-sterile |