FDA.reportPublic FDA data

Omnipod 5 Pod

Primary DI
10385083000213
Brand
Omnipod 5 Pod
Company
INSULET CORPORATION
Model
POD-BLE-H1-520
Device description
Omnipod 5 Pod
Published
2022-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QFGAlternate Controller Enabled Insulin Infusion Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFGAlternate Controller Enabled Insulin Infusion PumpClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203768000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203768000Omnipod 5 ACE Pump (Pod)Insulet Corporation2022-01-27QFG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385083000138PackageGS110In Commercial Distribution
10385083000213PackageGS15In Commercial Distribution
20385083000135PackageGS110In Commercial Distribution
20385083000210PackageGS15In Commercial Distribution
10385083000114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038508300013810385083000138
1038508300021310385083000213
2038508300013520385083000135
2038508300021020385083000210
1038508300011410385083000114

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump/interstitial glucose monitoring systemAn assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure700 KiloPascal1060 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature32 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-591-3455xxxx@xxx.com
1-800-591-3455RegulatoryAffairs@insulet.com
1-800-591-3455RA@insulet.com

Regulatory Flags#

DUNS number
051334402
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10385081120265Omnipod (Dash) Display App.1.3.1182392021-02-20
10385081120272Omnipod (Dash) View APP1.3.1182392021-02-20
10385083000411Omnipod 5 PodPOD-OMNI-I1-62202025-12-04
10385083000152Omnipod Discover B010-D-DP2025-12-04
20385083000425Omnipod 5 PodPOD-OMNI-I1-62202025-12-04
10385083000459Omnipod 5 Controller APPM009-2S-AP2025-12-01
10385081120333Omnipod PodPalsPOD-X9-990NS2025-04-16
10385083000114Omnipod 5 PodPOD-BLE-H1-5202022-02-25
10385083000527Omnipod 5 PodPOD-OMNI-I1-67202024-02-22
10385084000106Omnipod Go Insulin Delivery Device 10U/day PODPOD-INS-I1-10252023-08-18
10385084000151Omnipod Go Insulin Delivery Device 15U/dayPOD-INS-I1-15252023-08-18
10385084000205Omnipod Go Insulin Delivery Device 20U/dayPOD-INS-I1-20252023-08-18
10385084000250Omnipod Go Insulin Delivery Device 25U/dayPOD-INS-I1-25252023-08-18
10385084000304Omnipod Go Insulin Delivery Device 30U/dayPOD-INS-I1-30252023-08-18
10385084000359Omnipod Go Insulin Delivery Device 35U/dayPOD-INS-I1-35252023-08-18
10385084000403Omnipod Go Insulin Delivery Device 40U/dayPOD-INS-I1-40252023-08-18
20385081120330Omnipod PodPalsPOD-X9-990NS2025-04-16
10385081120234Omnipod PodPalsPOD-X9-9902019-07-01
10385082000009Omnipod DASH PDMPDM-USA1-D001-MG-USA12025-08-25
10385081120012OmnipodUST40018900-5A2018-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150077380MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-25
00199150021031MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-24
00763000848149MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-21
00763000848156MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-21
00850050080367iLet Insulin Infusion KitBeta Bionics, Inc.QFG2026-03-11
00850050080374iLet Starter KitBeta Bionics, Inc.QFG2026-03-11
00850050080381iLet Insulin Infusion KitBeta Bionics, Inc.QFG2026-03-11
00389152547244Tandem Mobi Mobile Application, AndroidTandem Diabetes Care, Inc.QFG2025-12-16
00389152858173Tandem t:slim Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152858777Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152859477Tandem t:slimTruSteel KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152852379Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152852973Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152853772Tandem Mobi Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152854373Tandem Mobi TruSteel KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152854977Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152855578Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152856179Tandem Mobi Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152856971Tandem t:slim Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152857572Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
10385083000411Omnipod 5 PodInsulet CorporationQFG2025-12-04
20385083000425Omnipod 5 PodInsulet CorporationQFG2025-12-04
00199150047055MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.QFG2025-11-08
00389152690940Tandem Mobi Mobile Application, iOSTandem Diabetes Care, Inc.QFG2025-10-06
00389152706474Pharmacy Kit, Starter Pack, Tandem t:slim X2, Control IQ+Tandem Diabetes Care, Inc.QFG2025-05-23
00389152707679Tandem t:slim Autosoft 30 kitTandem Diabetes Care, Inc.QFG2025-05-23
00389152708379Tandem t:slim AutoSoft XC KitTandem Diabetes Care, Inc.QFG2025-05-23
00389152708973Tandem t:slim Autosoft 30 kitTandem Diabetes Care, Inc.QFG2025-05-23
00389152709574Tandem t:slim AutoSoft XC KitTandem Diabetes Care, Inc.QFG2025-05-23
00389152710174Tandem t:slimTruSteel KitTandem Diabetes Care, Inc.QFG2025-05-23