FDA.reportPublic FDA data

Omnipod PodPals

Primary DI
10385081120333
Brand
Omnipod PodPals
Company
Insulet Corporation
Model
POD-X9-990NS
Device description
Omnipod Adhesive Overlay (PodPals) non-sterile
Published
2025-04-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20385081120330PackageGS110In Commercial Distribution
20385081120347PackageGS13In Commercial Distribution
10385081120333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2038508112033020385081120330
2038508112034720385081120347
1038508112033310385081120333

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, non-siliconeA long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
800-591-3455RA@insulet.com

Regulatory Flags#

DUNS number
051334402
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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
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
10385083000336Omnipod 5 Controller APPM009-S-AP2024-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00197344129099CURADMEDLINE INDUSTRIES, INC.KGX2026-06-09
08809302586364Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586395Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586425Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586487Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
00819143026446HealquHealqu LLCKGX2026-03-05
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31