CaviCide1
1 Minute 1 Step Germicidal Spray Fragrance Free
197manufacturers in China registered for this device type
6catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (49), Guangdong (34), Jiangsu (27). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Kingstar Medical (Xianning) Co., Ltd. | Xianning | Hubei | Contract manufacturer | 17 |
| Nantong City Yojo Medical Products Co., Ltd. | Haimen | Jiangsu | Contract manufacturer | 14 |
| Anqing Jiaxin Medical Technology Co., Ltd. | Anqing | Anhui | Contract manufacturer | 11 |
| Xiamen Yizhou IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 10 |
| Kingstar Industries (Wuhan) Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 10 |
| Hangzhou Wellbeing Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
Showing 12 of 197. All 197 manufacturers in China registered for Disinfectant, Medical Devices
Record
| Listed by | Metrex Research, United States |
|---|---|
| FDA product code | LRJ |
| Device type | Disinfectant, Medical Devices |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6890 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-31 |
| Record revised | 2023-04-04 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store In a Cool Place |
| Sizes | Total volume 2 to 24 Fluid Ounce; total volume 1 to 55 Gallon |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13-5008 | Total Volume 8 Fluid Ounce | In distribution |
| 13-5025 | Total Volume 2.5 Gallon | In distribution |
| 13-5000 | Total Volume 1 Gallon | In distribution |
| 13-5002 | Total Volume 2 Fluid Ounce | In distribution |
| 13-5055 | Total Volume 55 Gallon | In distribution |
| 13-5024 | Total Volume 24 Fluid Ounce | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 13 |
| Nuwave | Exceleron Medical, LLC | 11 |
| Biotrol | Young Dental Manufacturing I, LLC | 11 |
| VIDASHIELD/UV24 | Medical Illumination International, Inc | 10 |
| Hopkins Medical Products® | Hopkins Uniform Company | 10 |
| Yingtai | Changsha Yingtai Instrument Co., Ltd. | 9 |
| Emsrun | Wuxi Emsrun Technology Co., Ltd. | 9 |
| CaviWipes | Metrex Research | 8 |
| MedSource Antiseptic Towelettes | Medsource International, LLC | 8 |
| Mada Medical Products | Mada Medical Products, Inc. | 7 |
| Medline | Medline Industries, Inc. | 7 |
| Micro-Scientific Opti-Cide3 | Micro-Scientific, LLC | 7 |
Showing 12 of 120. All products under Disinfectant, Medical Devices
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K981023 | 1998-04-30 |
| K950516 | 1995-03-22 |
| K950553 | 1995-03-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | 50cs b. 38 c. 519gal d. 1671 e. 43.25cs f. 33btl g. unk |
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2017-01-20 | Class II | Packaging process control | Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process. | 960 cases | 2017-09-01 |
| 2012-02-06 | Class II | Component change control | Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected lot of product containing this fragance has caused an increase in reported health reactions in some individuals such as headache, nausea, and r | 17,690 units | 2012-08-24 |
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.