Azure
Azure Universal Patient Positioner
4manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Anhui (1), Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Senolo Medical Technology Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 12 |
| Anhui Yixiang Trading Co., Ltd. | Hefei | Anhui | Repacker / relabeller | 13 |
| Foshan Pingchuang Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
| Tianjin Grand Paper Industry Co., Ltd. | Tianjin | Tianjin | Manufacturer | 2 |
Record
| Listed by | Trulife, Inc., United States |
|---|---|
| FDA product code | JZR |
| Device type | Support Gels |
| Device class | Class 1 |
| Regulation | 21 CFR 866.4900 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AZ400G | In distribution | |
| AZ301 | In distribution | |
| AZ201G | In distribution | |
| AZ100 | In distribution | |
| AZ401G | In distribution | |
| AZ300 | In distribution | |
| AZ610 | In distribution | |
| AZ200 | In distribution | |
| AZ410 | In distribution | |
| AZ201 | In distribution | |
| AZ500 | In distribution | |
| AZ300G | In distribution | |
| AZ400 | In distribution | |
| AZ100G | In distribution | |
| AZ611 | In distribution | |
| AZ200G | In distribution | |
| AZ401 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oasis | Trulife, Inc. | 54 |
| Oasis Elite | Trulife, Inc. | 42 |
| Elite | Trulife, Inc. | 21 |
| Senolo | Jiangsu Senolo Medical Technology Co., Ltd. | 3 |
| Alilite Contour PAD, Small 15.75 Inch Long | Alimed, LLC | 1 |
| Alilite Closed Head Ring Adolescent | Alimed, LLC | 1 |
| Alilite Supine Adolescent Head Rest | Alimed, LLC | 1 |
| Alilite Table PAD | Alimed, LLC | 1 |
| Alilite Lateral LEG | Alimed, LLC | 1 |
| Alilite Supine Head Rest | Alimed, LLC | 1 |
| Alilite Closed Head Ring Adult | Alimed, LLC | 1 |
| Aliliteprone Torso Positioner | Alimed, LLC | 1 |
Showing 12 of 34. All products under Support Gels
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.