Dart
The DART Daily Air Removal Test is a pre-assembled Bowie-Dick test pack product used in monitoring healthcare steam sterilizers.
19manufacturers in China registered for this device type
2catalogue numbers in this listing
42510(k) clearances naming this product code
4recalls on this code
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 |
| Record published | 2016-09-09 |
| Record revised | 2026-02-09 (version 8) |
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 | Special storage condition: Keep away from direct light; Storage environment temperature 36 to 75 °F; Storage environment humidity 30 to 80 % RH |
| Packaging | Case of 5 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NB215 | 10 | In distribution | |
| NB113 | 10 | In distribution |
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 |
| 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 |
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
1 of these is Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-08-10 | Class III | Process control | Product contains incorrect chemical indicators in packaging. | 619 boxes | 2024-10-30 |
| 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.