AccessGUDID - DEVICE: V-Go Disposable Insulin Delivery (00385609400018)

GUDID

Device Identifier (DI) Information

Brand Name: V-Go Disposable Insulin Delivery
Version or Model: V-Go 40
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8560-9400-01
Company Name: MANNKIND CORPORATION

Primary DI Number: 00385609400018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 099981040 *Terms of Use

Device Description: 40 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
51081	Ambulatory insulin infusion pump, mechanical	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZG	Pump, Infusion, Insulin

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: .76 Milliliter

Device Record Status

Public Device Record Key: 3e08bbb3-e3ba-4670-9d04-3e13e702e585
Public Version Date: April 03, 2024
Public Version Number: 8
DI Record Publish Date: May 24, 2016