Accu-Chek Aviva Combo
Accu-Chek Aviva Combo MG/DL (670)
7manufacturers in China registered for this device type
1catalogue number
1recall
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 | Roche Diagnostics Operations, United States |
|---|---|
| FDA product code | LZG |
| Device type | Pump, Infusion, Insulin |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Record published | 2016-08-08 |
| Record revised | 2023-07-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2021-10-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05075645005 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OneTouch Ping | Animas Corp. | 12 |
| Easy Release | Sooil Development Co., Ltd. | 9 |
| V-Go Disposable Insulin Delivery | Mannkind Corporation | 6 |
| 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 |
Showing 12 of 53. All products under Pump, Infusion, Insulin
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-09-25 | Class II | Equipment maintenance | The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default setting. Though the pump prompts customers t | 8116 | 2018-01-10 |
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.