DEVICE: V-Go Disposable Insulin Delivery (00385609600036)

Device Identifier (DI) Information

V-Go Disposable Insulin Delivery
V-Go 20
In Commercial Distribution
8560-9600-03
VALERITAS, INC.
00385609600036
GS1

6
800531092 *Terms of Use
20 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments
CLOSE

Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Insulin infusion patch pump, mechanical A badge-like, mechanical (non-electric) device designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive) to provide basal and/or periodic bolus subcutaneous delivery of insulin to a patient with diabetes mellitus. The device typically integrates a needle(s)/infusion cannula and an insulin 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LZG Pump, Infusion, Insulin
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K103825 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 140 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Total Volume: .56 Milliliter
CLOSE

Device Record Status

6bd717e8-5467-4100-a170-47091193f1bd
July 06, 2018
3
May 24, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10385609600033 10 00385609600036 In Commercial Distribution carton
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 00385600000200 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-866-881-1209
xx@xx.xx
CLOSE