FDA Registration Active 🇺🇸 United States

V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20 (6-pack)

Reg #: 1226572 · FEI: 3003154078 · Expires 2025
Products
2
Proprietary Names
6
Establishment Types
2
Classifications
2

Registration Details

Registration Name
MannKind Corporation - V-Go
Registration Number
1226572
FEI Number
3003154078
Status
Active
Expiry Year
2025
Initial Importer
No
Address
293 Boston Post Road W, # 330
City
Marlborough
State
MA
ZIP
01752
Country
US

Regulatory Submissions

510(k) Number
K100504

Owner / Operator

Firm Name
MannKind Corporation
Operator Number
10056720
Address
One Casper Street
City
Danbury
State
CT
Postal Code
06810
Country
US
Correspondent
Robyn Walsh

Products

Device Name Product Code
Set, Administration, Intravascular FPA
Pump, Infusion, Insulin LZG

Proprietary Names

V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20 (6-pack) V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20 (30-pack) V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO40 (30-pack) V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 30 (30-pack) V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO40 (6-pack) V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 30 (6-pack)

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility