Verify
The VERIFY Process Indicator for the Reliance EPS Endoscope Processing System is a peracetic acid concentration indicator that changes color to the ENDPOINT reference block upon exposure to…
The VERIFY Process Indicator for the Reliance EPS Endoscope Processing System is a peracetic acid concentration indicator that changes color to the ENDPOINT reference block upon exposure to an effective dose of peracetic acid. It is intended for use for routine monitoring of the Reliance EPS Endoscope Processing System employing Reliance DG Dry Germicide.
Who Else Makes It
Concentrated in Guangdong (7), Anhui (4), Hubei (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Shanghai Jianzhong Medical Packaging Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 3 |
| Dongguan Safesecure Medical Packaging Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Jiangsu Jsongmed Medical Material Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 2 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Wellmed Dental Medical Supply Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 37 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Anhui Ares Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 28 |
| Bgss Company Asia Limited | Zhabei | Shanghai | Contract manufacturer | 25 |
Showing 12 of 19. All 19 manufacturers in China registered for Indicator, Physical/Chemical Sterilization Process
Record
| Listed by | Albert Browne Ltd., United Kingdom |
|---|---|
| FDA product code | JOJ |
| Device type | Indicator, Physical/Chemical Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K002741 |
| Record published | 2016-09-06 |
| Record revised | 2025-02-21 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 32 to 86 °F; Storage environment humidity 30 to 60 % RH; Special storage condition: Avoid Direct Light |
| Packaging | Box of 2, box of 20 |
| Distribution end date | 2025-04-29 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PCC038 | 200 | In distribution | |
| Bowie Dick | In distribution | ||
| PCC005 | 200 | In distribution | |
| RK019 | 100 | In distribution | |
| PCC061 | 200 | In distribution | |
| PCC007 | 100 | In distribution | |
| PCC031 | 100 | In distribution | |
| PCC034 | 100 | In distribution | |
| PCC006 | 200 | In distribution | |
| PCC037 | 200 | In distribution | |
| PCC009 | 250 | In distribution | |
| LCC016 | 60 | In distribution | |
| PCC008 | 100 | In distribution | |
| LCC310 | 100 | In distribution | |
| LCC005 | 100 | Withdrawn | |
| LCC016 | 60 | Withdrawn | |
| PCC029 | 60 | Withdrawn | |
| RK019 | 100 | Withdrawn | |
| LCC016 | 60 | Withdrawn | |
| PCC033 | 100 | Withdrawn | |
| PCC029 | 60 | Withdrawn | |
| PCC003 | 250 | Withdrawn | |
| PCC046 | 200 | Withdrawn | |
| PCC048 | 1,000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy | HU-Friedy MFG Co., LLC | 32 |
| JMU | JMU Dental, Inc | 32 |
| MARK3 | Cargus International, Inc | 28 |
| Comply™ | 3M Company | 25 |
| Cardinal Health | Cardinal Health 200, LLC | 19 |
| Verify | Steris Corporation | 18 |
| McKesson | Mckesson Medical-Surgical Inc. | 16 |
| Sklar® | Sklar Corporation | 14 |
| Case Medical | Case Medical, Inc. | 13 |
| Dental City | ICP, Inc. | 13 |
| PlastCare | Proguard Health Inc. | 12 |
| PeelVue Pro | Kerr Corporation | 12 |
Showing 12 of 278. All products under Indicator, Physical/Chemical Sterilization Process
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K063285 | 2007-01-12 |
| K061738 | 2006-08-25 |
| K053479 | 2006-07-18 |
| K060066 | 2006-03-24 |
| K060103 | 2006-03-07 |
| K051101 | 2005-12-06 |
| K032801 | 2003-10-17 |
| K002741 | 2002-07-03 |
| K012335 | 2001-10-01 |
| K992767 | 2000-01-10 |
| K991709 | 1999-10-08 |
| K991418 | 1999-06-10 |
| K984613 | 1999-02-04 |
| K984616 | 1999-02-04 |
| K981054 | 1998-12-07 |
| K971369 | 1998-01-29 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Steris Corporation | 510(k) number | 2022-08-10 | Class III | Process control | Product contains incorrect chemical indicators in packaging. | 619 boxes | 2024-10-30 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2003-02-25 | Not classified | Other | Moisture ingress into packaging of test strips may cause premature failure. | 4,112 cases of two bottles each. 60 strips per bottle. | 2004-05-17 |
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.