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 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 |
KGX | Tape And Bandage, Adhesive |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-07-09 |
Device Publish Date | 2019-07-01 |
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20385084000158 - Omnipod Go Insulin Delivery Device 15U/day | 2023-08-28 Omnipod Go Insulin Delivery Device 15U/day |
20385084000202 - Omnipod Go Insulin Delivery Device 20U/day | 2023-08-28 Omnipod Go Insulin Delivery Device 20U/day |
20385084000257 - Omnipod Go Insulin Delivery Device 25U/day | 2023-08-28 Omnipod Go Insulin Delivery Device 25U/day |
20385084000301 - Omnipod Go Insulin Delivery Device 30U/day | 2023-08-28 Omnipod Go Insulin Delivery Device 30U/day |
20385084000356 - Omnipod Go Insulin Delivery Device 35U/day | 2023-08-28 Omnipod Go Insulin Delivery Device 35U/day |
20385084000400 - Omnipod Go Insulin Delivery Device 40U/day | 2023-08-28 Omnipod Go Insulin Delivery Device 40U/day |