Erin Beach Chair Face Mask
Catalogue number 711001, listed by Aspen Surgical Products, Inc., United States, under Support, Patient Position. 66 manufacturers in China are registered for this product code.
66manufacturers in China registered for this device type
1catalogue number
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (18), Zhejiang (16), Guangdong (11). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
| Jinhua Ivy Home Textile Co., Limited | Jinhua | Zhejiang | Contract manufacturer | 18 |
| Shenzhen Zhouyang Medical Care Product Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Metacare Industrial Ltd | Guangzhou | Guangdong | Contract manufacturer | 17 |
| Jiangsu Classic NEW-Type Medical Products Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 13 |
| Kunshan Jiehong Nonwoven Product Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 12 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Anhui Ivymed Medical Products Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 10 |
| Suzhou Baili Medical Supplies Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
Showing 12 of 66. All 66 manufacturers in China registered for Support, Patient Position
Record
| Listed by | Aspen Surgical Products, Inc., United States |
|---|---|
| FDA product code | CCX |
| Device type | Support, Patient Position |
| Device class | Class 1 |
| Regulation | 21 CFR 868.6820 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-03-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 711001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 225 |
| Soule Medical | Soule Co., THE | 212 |
| Coulmed | Coulmed Products Group LLC | 135 |
| Techno-Aide | Techno-Aide, Inc. | 108 |
| BoneFoam | Bone Foam Inc. | 93 |
| Halyard | Owens & Minor Distribution, Inc. | 80 |
| Devon | Cardinal Health | 75 |
| Domico Med-Device | Domico Med-Device, LLC | 69 |
| Universal Lateral Positioner® | Innovative Medical Products, Inc. | 69 |
| Lateral Patient Positioning System | Alphatec Spine, Inc. | 65 |
| Cardinal Health | Cardinal Health 200, LLC | 64 |
| Pediatric Patient Positioner | Alphatec Spine, Inc. | 55 |
Showing 12 of 1,485. All products under Support, Patient Position
Recalls
3 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 |
|---|---|---|---|---|---|
| 2021-07-23 | Class II | Process control | Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product’s sterilization process was validated. As a result, the firm cannot provide full assurance that the affected product | 124 | 2022-07-26 |
| 2021-07-23 | Class II | Process control | Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product’s sterilization process was validated. As a result, the firm cannot provide full assurance that the affected product | 4270 | 2022-07-26 |
| 2021-07-23 | Class II | Process control | Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product’s sterilization process was validated. As a result, the firm cannot provide full assurance that the affected product | 1429 | 2022-07-26 |
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.