3m™ Attest™
The 3M Attest Steam Chemical Integrator monitors steam sterilisation conditions inside a pack, pouch, container or tray. It responds to the combined effects of steam, exposure time and…
The 3M Attest Steam Chemical Integrator monitors steam sterilisation conditions inside a pack, pouch, container or tray. It responds to the combined effects of steam, exposure time and temperature during its specified sterilisation cycles.
A temperature- and steam-sensitive chemical pellet melts and migrates as a dark colour along a paper wick. A window marked accept or reject shows how far the material has moved, providing the visible integrator result.
Listed Item
3M™ Attest™ Steam Chemical Integrator w/Ext & Adh, 1243RA, Type 5,3/4 in x 2 in (1.9 cm x 5.1 cm), 500/BAG, 2 BAG/CS, 1000/CS
Cycle Matching
The integrator is intended for the specified gravity and dynamic-air-removal steam cycles. The selected cycle’s time and temperature must fall within those defined for the product; the integrator is an independent process monitor inside the load packaging.
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 | 3M Company, 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K191236 |
| Record published | 2026-04-26 |
| Record revised | 2025-02-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 2, pack of 2, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1243RA | 500 | In distribution | |
| 1243RES | 500 | In distribution | |
| 1243A | 500 | In distribution | |
| 1243RE | 500 | In distribution | |
| 1243B | 100 | 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 |
|---|---|
| K222508 | 2022-11-01 |
| K222152 | 2022-09-23 |
| K220942 | 2022-06-24 |
| K220564 | 2022-05-23 |
| K212081 | 2021-09-05 |
| K203458 | 2020-12-11 |
| K203285 | 2020-12-10 |
| K193254 | 2019-12-23 |
| K191236 | 2019-11-22 |
| K192937 | 2019-11-16 |
| K192673 | 2019-10-28 |
| K183211 | 2019-02-26 |
| K183209 | 2019-02-15 |
| K170321 | 2017-08-14 |
| K170563 | 2017-07-27 |
| K150694 | 2015-10-01 |
| K150622 | 2015-09-29 |
| K150477 | 2015-07-02 |
| K101528 | 2010-10-01 |
| K101249 | 2010-09-08 |
| K093199 | 2009-12-04 |
| K020589 | 2002-04-22 |
| K932129 | 1994-03-04 |
| K801057 | 1980-06-17 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| 3M Company | UDI-DI | 2023-04-06 | Class II | Process control | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle. | 16,229,000 units |
| 3M Company | UDI-DI | 2023-04-06 | Class II | Process control | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle. | 2,235,000 units |
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 |
|---|---|---|---|---|---|
| 2008-03-19 | Not classified | Nonconforming Material/Component | A production specification discrepancy may cause the indicators to show an inaccurate result, which could incorrectly lead customers to conclude the sterilization cycle was adequate. | 12,998 cases ( 4 boxes per case & 480 strips per box)) | 2012-03-01 |
| 2006-08-09 | Not classified | Other | 3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing. | 6248 cases (4 boxes/case) | 2007-05-25 |
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.