Verify
VERIFY VH2O2 Indicator Tape is coated crepe paper with diagonal lines of a chemical indicator specific to hydrogen peroxide sterilization. The filing says the tape secures items wrapped in…
VERIFY VH2O2 Indicator Tape is coated crepe paper with diagonal lines of a chemical indicator specific to hydrogen peroxide sterilization.
The filing says the tape secures items wrapped in synthetic materials until use and distinguishes processed from unprocessed units through color change.
Listed Item
The VERIFY VH202 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change. It can be changed in all V-PRO Low Temperature Sterilization Systems and Sterrad 100S, NX and 100NX Sterilizers.
Intended Use and Indicator
The stated start color is pink, changing to peach, yellow or lighter. The filing identifies it as a Type 1 process indicator and lists V-PRO and STERRAD sterilization cycles, including the Non Lumen, Flexible and Lumen cycles of V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizers.
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 | Steris Corporation, United States |
|---|---|
| FDA product code | JOJ |
| Device type | Indicator, Physical/Chemical Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K160485 |
| Record published | 2020-01-06 |
| Record revised | 2025-02-21 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment humidity 30 to 60 % RH; Storage environment temperature 16 to 24 °C; Special storage condition: Keep dry and away from sunlight. Do Not store near heat, moisture, oxidizing agents, acids/alkalis, or cleaning/disinfec |
| Packaging | Case of 2, case of 8, case of 4, box of 20, case of 6 |
| Sizes | Width 0.75 in; length 4 in; length 60 Yard |
| Distribution end date | 2022-11-02 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PCC071 | Length 60 Yard | 6 | In distribution |
| STEAM Integrating | Width 0.75 in | 250 | In distribution |
| PCC067 | 500 | In distribution | |
| LCB036 | In distribution | ||
| Bowie Dick | In distribution | ||
| PCC066 | Length 4 in | 200 | In distribution |
| S3095 | 31 | In distribution | |
| EQC004 | 100 | In distribution | |
| LCB035 | In distribution | ||
| LCB037 | In distribution | ||
| STEAM Integrating | Length 4 in | 1,000 | In distribution |
| PCC070 | Length 60 Yard | Withdrawn | |
| LCB005 | 5 | Withdrawn | |
| LCB039 | Withdrawn | ||
| LCB041 | Withdrawn | ||
| Bowie Dick | 20 | Withdrawn | |
| PCC039 | 250 | Withdrawn | |
| LCB040 | 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 |
| Verify | Albert Browne Ltd. | 24 |
| Cardinal Health | Cardinal Health 200, LLC | 19 |
| 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 |
|---|---|
| K251048 | 2025-05-02 |
| K243876 | 2025-04-25 |
| K243475 | 2024-12-04 |
| K242189 | 2024-08-20 |
| K241344 | 2024-06-11 |
| K240032 | 2024-04-17 |
| K240760 | 2024-04-10 |
| K233654 | 2023-12-08 |
| K233187 | 2023-10-27 |
| K231488 | 2023-08-07 |
| K230558 | 2023-07-17 |
| K192020 | 2019-09-05 |
| K183293 | 2019-01-04 |
| K182724 | 2018-12-10 |
| K173428 | 2018-03-02 |
| K172746 | 2018-02-09 |
| K172753 | 2018-02-09 |
| K172472 | 2017-11-17 |
| K162758 | 2017-03-21 |
| K162631 | 2017-01-27 |
| K160485 | 2016-06-01 |
| K152630 | 2016-05-12 |
| K143333 | 2015-04-14 |
| K140515 | 2014-07-17 |
| K130160 | 2013-08-16 |
| K120435 | 2012-06-04 |
| K112256 | 2012-01-11 |
| K103331 | 2011-09-01 |
| K103053 | 2011-03-10 |
| K102296 | 2011-02-09 |
| K102217 | 2010-11-22 |
| K091174 | 2009-10-27 |
| K083643 | 2009-08-07 |
| K081600 | 2008-08-22 |
| K081427 | 2008-06-11 |
| K080750 | 2008-05-12 |
| K073683 | 2008-01-25 |
| K072510 | 2007-12-11 |
| K071895 | 2007-11-14 |
| K070895 | 2007-09-05 |
| K070461 | 2007-07-17 |
| K043482 | 2004-12-21 |
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
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 |
|---|---|---|---|---|---|
| 2013-12-19 | Class II | Labeling False and Misleading | STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A. | 94 boxes/20 units | 2014-03-26 |
| 2011-03-16 | Not classified | Labeling False and Misleading | During an inspection the firm was notified that language contained in labeling and promotional literature directs Customers that the products can be used to replace biological indicators and/or release loads containing implants. | 2,500 | 2013-03-19 |
| 2011-03-16 | Not classified | Labeling False and Misleading | During an inspection the firm was notified that language contained in labeling and promotional literature directs Customers that the products can be used to replace biological indicators and/or release loads containing implants. | 2,500 (one per customer) | 2013-03-19 |
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.