Primary Device ID | 10385081120265 |
NIH Device Record Key | 2f4cb276-8c75-4958-880a-83cc0bcd4460 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Omnipod (Dash) Display App. |
Version Model Number | 1.3.1 |
Catalog Number | 18239 |
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 | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
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 | false |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com | |
Phone | 978-600-7155 |
RA@insulet.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10385081120265 [Primary] |
PKU | Insulin Pump Secondary Display |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-03-01 |
Device Publish Date | 2021-02-20 |
20385084000103 - Omnipod Go Insulin Delivery Device 10U/day POD | 2023-08-28 Omnipod Go Insulin Delivery Device 10U/day POD |
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 |
10385081120302 - Omnipod 5 Controller APP | 2022-03-07 Actual downloadable APP, called Omnipod 5 Controller APP |