FDA.reportPublic FDA data

V-Go Disposable Insulin Delivery

Primary DI
00385609600036
Brand
V-Go Disposable Insulin Delivery
Company
MANNKIND CORPORATION
Model
V-Go 20
Catalog number
8560-9600-03
Device description
20 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments
Published
2016-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZGPump, Infusion, Insulin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZGPump, Infusion, InsulinGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103825000V-GO INSULIN DELIVERY SYSTEMValeritas, Inc.2011-02-23LZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385609600033PackageGS110In Commercial Distribution
00385609600036PrimaryGS10
00385600000200Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038560960003310385609600033
00385609600036003856096000363856096000360385609600036
00385600000200003856000002003856000002000385600000200

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump, mechanicalA portable, mechanical (non-electric) device designed to provide basal and/or periodic bolus subcutaneous delivery of insulin (not included) to a patient with diabetes mellitus. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. The device typically integrates a needle(s)/infusion cannula and reservoir; it is patient operated (e.g., by squeezing/pressing buttons) and may be daily-disposable or used for several days before being discarded. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.56Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Fahrenheit140 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-866-881-1209xx@xx.xx

Regulatory Flags#

DUNS number
099981040
Device count
6
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385609400018V-Go Disposable Insulin DeliveryV-Go 408560-9400-012016-05-24
00385609400032V-Go Disposable Insulin DeliveryV-Go 208560-9400-032016-05-24
00385609600012V-Go Disposable Insulin DeliveryV-Go 408560-9600-012016-05-24
00385609600029V-Go Disposable Insulin DeliveryV-Go 308560-9600-022016-05-24
00385609400025V-Go Disposable Insulin DeliveryV-Go 308560-9400-022016-05-24
00347918000037BluHale PRO™PRO-MKC2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850037806034PIVOT Insulin Pump ReplacementModular Medical, Inc.LZG2026-05-26
00850037806072PIVOT InserterModular Medical, Inc.LZG2026-05-26
00850037806133PIVOT Supply Kit (1pk)Modular Medical, Inc.LZG2026-05-26
00850037806164Pivot App for iOSModular Medical, Inc.LZG2026-05-26
00850037806089PIVOT Supply Kit (5pk)Modular Medical, Inc.LZG2026-05-18
00850037806140PIVOT Insulin Pump Starter KitModular Medical, Inc.LZG2026-05-18
10385082000009Omnipod DASH PDMInsulet CorporationLZG2025-08-25
00850037806003MODD1 Adhesive Pad, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806027MODD1 Insulin Cartridge, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806041MODD1 Infusion Set, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806096MODD1 PumpModular Medical, Inc.LZG2025-07-11
10850037806000MODD1 Adhesive Pad, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806010MMI App for iOSModular Medical, Inc.LZG2025-07-11
10850037806024MODD1 Insulin Cartridge, 10 PackModular Medical, Inc.LZG2025-07-11
10850037806048MODD1 Infusion Set, 10 PackModular Medical, Inc.LZG2025-07-11
00850037806065MODD1 Supply KitModular Medical, Inc.LZG2025-07-11
00850037806102MODD1 PumpModular Medical, Inc.LZG2025-07-11
00850037806119MODD1 Starter KitModular Medical, Inc.LZG2025-07-11
00850037806126MODD1 Patient Welcome KitModular Medical, Inc.LZG2025-07-11
10385084000106Omnipod Go Insulin Delivery Device 10U/day PODInsulet CorporationLZG2023-08-18
10385084000151Omnipod Go Insulin Delivery Device 15U/dayInsulet CorporationLZG2023-08-18
10385084000205Omnipod Go Insulin Delivery Device 20U/dayInsulet CorporationLZG2023-08-18
10385084000250Omnipod Go Insulin Delivery Device 25U/dayInsulet CorporationLZG2023-08-18
10385084000304Omnipod Go Insulin Delivery Device 30U/dayInsulet CorporationLZG2023-08-18
10385084000359Omnipod Go Insulin Delivery Device 35U/dayInsulet CorporationLZG2023-08-18
10385084000403Omnipod Go Insulin Delivery Device 40U/dayInsulet CorporationLZG2023-08-18
20385084000103Omnipod Go Insulin Delivery Device 10U/day PODINSULET CORPORATIONLZG2023-08-18
20385084000158Omnipod Go Insulin Delivery Device 15U/dayINSULET CORPORATIONLZG2023-08-18
20385084000202Omnipod Go Insulin Delivery Device 20U/dayINSULET CORPORATIONLZG2023-08-18
20385084000257Omnipod Go Insulin Delivery Device 25U/dayINSULET CORPORATIONLZG2023-08-18