AN1087 Dosimeter, Chemical Indicator
The AN1087 Dosimeter is a chemical indicator for checking cumulative ethylene oxide exposure in the Andersen EOGas 4 sterilizer. It is calibrated for the three-hour sterilization cycle at…
The AN1087 Dosimeter is a chemical indicator for checking cumulative ethylene oxide exposure in the Andersen EOGas 4 sterilizer. It is calibrated for the three-hour sterilization cycle at 50°C and is intended for a single use.
A pH indicator inside a glass capillary changes from yellow-orange to dark blue as ethylene oxide exposure progresses. The colored region advances from the open end toward the sealed end, and its extent reflects cumulative exposure.
Listed Item
AN1087.00 Dosimeter, Chemical Indicator, 25 units
Reading the Indicator
A calibration mark indicates the specified cumulative exposure at the dosimeter location. The indicator responds to gas concentration and time within the calibrated temperature conditions. It complements the sterilization monitoring process and does not replace a biological indicator.
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 | Andersen Sterilizers, Inc., United States |
|---|---|
| FDA product code | JOJ |
| Device type | Indicator, Physical/Chemical Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K150645 |
| Record published | 2018-09-01 |
| Record revised | 2025-02-21 (version 3) |
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, manufacturing date |
| Storage | Storage environment temperature 20 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AN1087.00 | 25 | In distribution | |
| AN1087.16 | 16 | 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 |
|---|---|
| K200334 | 2020-11-12 |
| K170439 | 2017-11-01 |
| K170426 | 2017-10-30 |
| K150645 | 2015-11-19 |
| K150644 | 2015-11-18 |
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.