Comply™
3M™ Comply™ Bowie-Dick Plus Test Pack with Early Warning Test Sheet 00135LF
19manufacturers in China registered for this device type
25catalogue numbers in this listing
24510(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 | 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 |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2025-02-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5, box of 20, box of 4, box of 2, box of 12, box of 8 |
| Distribution end date | 2018-04-28 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1251 | 240 | In distribution | |
| 1322-12MM | 42 | In distribution | |
| 00135LF | 6 | In distribution | |
| 1355-18MM | 28 | In distribution | |
| 3987 | 60 | In distribution | |
| 1233LF | 6 | In distribution | |
| 1228 | 24 | In distribution | |
| 1250 | 240 | In distribution | |
| 1322-18MM | 28 | In distribution | |
| 1322-24MM | 20 | In distribution | |
| 00132LF | 6 | In distribution | |
| 6600 | 250 | In distribution | |
| 1355-24MM | 20 | In distribution | |
| 00130LF | 50 | In distribution | |
| 3983MM | 60 | In distribution | |
| 1248 | 250 | In distribution | |
| 1322-48MM | 10 | In distribution | |
| 1248 | 250 | In distribution | |
| 1224-1 | 18 | Withdrawn | |
| 00160 | Withdrawn | ||
| 00117 | 200 | Withdrawn | |
| 1224-6 | 24 | Withdrawn | |
| 1224-0 | 36 | Withdrawn | |
| 00118 | 200 | Withdrawn | |
| 00119 | 200 | 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 |
| 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 |
| PeelVue Pro | Kerr Corporation | 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
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 III | 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. | a. 12 bags, b. 4 bags |
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 |
|---|---|---|---|---|---|
| 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 | |
| 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 | |
| 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.