Sample Pack, Axess Mask 3 Pcs
Catalogue number 28534, listed by Accutron, Inc., United States, under Mask, Scavenging. 158 manufacturers in China are registered for this product code.
158manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (27), Guangdong (27), Hubei (27). 25 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Henan Huibo Medical Co., Ltd. | Nanyang | Henan | Contract manufacturer | 17 |
| Hubei Wanli Protective Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 15 |
| Qingdao Likangyuan Medical Device Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 14 |
| Hubei Weikang Protective Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 12 |
| Jiaxing Xinyi Medical Instrument Co., Ltd. | Jiashan | Zhejiang | Contract manufacturer | 12 |
| Polyzon Sciences Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 12 |
Showing 12 of 158. All 158 manufacturers in China registered for Mask, Scavenging
Record
| Listed by | Accutron, Inc., United States |
|---|---|
| FDA product code | KHA |
| Device type | Mask, Scavenging |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5590 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2018-12-14 |
| Record revised | 2023-09-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28534 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AirTechniques | Baldus Sedation GmbH & Co. KG | 15 |
| MacSafe | Surgimac LLC | 8 |
| Dual Nasal Hood For Anesthesia with LuerSafe CO2 Monitoring Single Use Large Min | Flexicare Medical Ltd. | 6 |
| ClearView Nasal Mask and Capnography Bundle → Adult Birthday Bubblegum (pkg.12) | Accutron, Inc. | 5 |
| ClearView Nasal Mask and Capnography Bundle → Pediatric Birthday Bubblegum pkg12 | Accutron, Inc. | 5 |
| ClearView Nasal Mask and Capnography Bundle → Large Adult Outlaw Orange (pkg.12) | Accutron, Inc. | 4 |
| Britedent | Bright Supply Inc | 2 |
| Solidex | Creo Dent Hudson Valley, Inc. | 2 |
| Safe Dent | Bgss Company Inc | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Nasal Hood For Anesthesia Reusable Small | Flexicare Medical Ltd. | 1 |
| Matrx Scav,w/SM Hood(WO/Shutof | Parker Hannifin Corp. | 1 |
Showing 12 of 180. All products under Mask, Scavenging
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K970046 | 1997-03-28 |
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.