V-Go Disposable Insulin Delivery
20 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments
7manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (3), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Viant Medical Suzhou EPZ Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Mannkind Corporation, United States |
|---|---|
| FDA product code | LZG |
| Device type | Pump, Infusion, Insulin |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K103825 |
| Record published | 2016-05-24 |
| Record revised | 2024-04-03 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 140 °F |
| Packaging | Carton of 10, carton of 4 |
| Sizes | Total volume 0.56 to 0.76 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| V-Go 20 | Total Volume.56 ml | 6 | In distribution |
| V-Go 40 | Total Volume.76 ml | 6 | In distribution |
| V-Go 30 | Total Volume.66 ml | 30 | In distribution |
| V-Go 40 | Total Volume.76 ml | 30 | In distribution |
| V-Go 20 | Total Volume.56 ml | 30 | In distribution |
| V-Go 30 | Total Volume.66 ml | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OneTouch Ping | Animas Corp. | 12 |
| Easy Release | Sooil Development Co., Ltd. | 9 |
| Accu-Chek Combo | Roche Diabetes Care, Inc. | 5 |
| Superline | Sooil Development Co., Ltd. | 4 |
| t:slim Cartridge, t:lock, 10 Pack | Tandem Diabetes Care, Inc. | 3 |
| Dana Diabecare | Sooil Development Co., Ltd. | 3 |
| Accu-Chek Spirit Cartridge | Roche Diabetes Care, Inc. | 2 |
| t:slim X2 Insulin Pump | Tandem Diabetes Care, Inc. | 2 |
| Omnipod | Insulet Corporation | 2 |
| Soft-Release-ST | Sooil Development Co., Ltd. | 2 |
| t:slim Insulin Pump, Replacement | Tandem Diabetes Care, Inc. | 1 |
| MODD1 Infusion Set, 10 Pack | Modular Medical | 1 |
Showing 12 of 53. All products under Pump, Infusion, Insulin
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Valeritas, Inc. | 510(k) number | 2019-07-03 | Class II | Employee error | There is a potential for “No Needle Demo Units” to contain a needle. | 49,074 devices | 2020-06-24 |
| Valeritas, Inc. | 510(k) number | 2019-07-03 | Class II | Employee error | There is a potential for “No Needle Demo Units” to contain a needle. | 20,532 devices | 2020-06-24 |
| Valeritas, Inc. | 510(k) number | 2019-07-03 | Class II | Employee error | There is a potential for “No Needle Demo Units” to contain a needle. | 21,714 devices | 2020-06-24 |
| Valeritas, Inc. | 510(k) number | 2019-07-03 | Class II | Employee error | There is a potential for “No Needle Demo Units” to contain a needle. | 852 devices | 2020-06-24 |
| Valeritas, Inc. | 510(k) number | 2019-07-03 | Class II | Employee error | There is a potential for “No Needle Demo Units” to contain a needle. | 60 devices | 2020-06-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.