DEVICE: V-Go Disposable Insulin Delivery (00385609600012)

Device Identifier (DI) Information

V-Go Disposable Insulin Delivery
V-Go 40
In Commercial Distribution
8560-9600-01
VALERITAS, INC.
00385609600012
GS1

6
800531092 *Terms of Use
40 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments
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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
Ambulatory insulin infusion pump, mechanical A portable, mechanical (non-electric) device designed to provide basal and/or periodic bolus subcutaneous delivery of insulin 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 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.
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FDA Product Code

[?]
Product Code Product Code Name
LZG Pump, Infusion, Insulin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K103825 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 140 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: .76 Milliliter
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Device Record Status

037de6e6-2098-4c5f-b182-dc7a7f6bb553
September 12, 2018
4
May 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10385609600019 10 00385609600012 In Commercial Distribution carton
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00385600000408 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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