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V-Go Disposable Insulin Delivery

FDA UDI

Class II (US FDA UDI)

by Mannkind Corporation

Identity

Trade Name
V-Go Disposable Insulin Delivery FDA UDI
Generic Name
Ambulatory insulin infusion pump, mechanical FDA UDI
Device Name
30 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments FDA UDI
Model / Reference
V-Go 30 FDA UDI
Description
30 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments FDA UDI

Identifiers

Catalog Number
8560-9400-02 FDA UDI
Primary DI / UDI-DI
00385609400025 FDA UDI
510(k) Number
K103825 FDA UDI
FDA Product Code
LZG FDA UDI
GMDN Term
Ambulatory insulin infusion pump, mechanical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Total Volume — .66 Milliliter FDA UDI

Category: Ambulatory insulin infusion pump, mechanical

V-Go Disposable Insulin Delivery by Mannkind Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory insulin infusion pump, mechanical.

Cleared under the same submission

K103825 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mannkind Corporation

Sources (1)

  • FDA UDI d554575d-dce0-4045-b695-131ffbaf67fb 38 fields · synced May 30, 2026