Rad-Sure™
Blood Irradiation Indicator
3manufacturers in China registered for this device type
20catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (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 |
|---|---|---|---|---|
| Shenzhen Lilian Precision Mould Manufacturing Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Goju Identification Technology Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Ashland Specialty Ingredients, G.P., United States |
|---|---|
| FDA product code | KSS |
| Device type | Supplies, Blood-Bank |
| Device class | Class 1 |
| Regulation | 21 CFR 864.9050 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-06 |
| Record revised | 2023-02-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-10-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25 Gy @200SH | In distribution | |
| 15 Gy @200SH | In distribution | |
| 15 Gy Sample @24SH (consolidated XR/G) | In distribution | |
| 25 Gy Sample @24SH (consolidated XR/G) | In distribution | |
| 25 Gy NBF @200EA | In distribution | |
| 25 Gy NBF Sample @24EA (consolidated) | In distribution | |
| UVA-3J Indicator Sample @24EA | Withdrawn | |
| ChromicVue™ 25 Gy @250 | Withdrawn | |
| XR 15 Gy (x200) | Withdrawn | |
| ChromicVue™ 25 Gy | Withdrawn | |
| XR 25 Gy NBF (200 EA) | Withdrawn | |
| 25 Gy (x200) | Withdrawn | |
| 25 Gy NBF (x200) | Withdrawn | |
| XR 25 GY Indicator Sample @24EA | Withdrawn | |
| XR 15 GY Indicator Sample @24EA | Withdrawn | |
| XR 25 Gy (x200) | Withdrawn | |
| ChromicVue™ XR 15 Gy | Withdrawn | |
| ChromicVue™ 15 Gy | Withdrawn | |
| ChromicVue™ XR 25 Gy | Withdrawn | |
| 15 Gy (x200) | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RadTag | Radtag Technologies, Inc. | 12 |
| Cascade | Musculoskeletal Transplant Foundation | 5 |
| MTS | Micro Typing Systems, Inc. | 5 |
| Capture Liss | Immucor, Inc. | 5 |
| GPS® III Platelet Concentration System | Biomet Biologics, LLC | 4 |
| MacoPress Smarter | Delcon SRL | 4 |
| Marketlab Inc | Marketlab Incorporated | 4 |
| Capture-P | Immucor, Inc. | 3 |
| GPS® III | Biomet Biologics, LLC | 2 |
| Typesafe 2.0 | Typenex Medical, LLC | 2 |
| Capture-P Indicator Red Cells | Immucor, Inc. | 2 |
| Typesafe | Typenex Medical, LLC | 2 |
Showing 12 of 48. All products under Supplies, Blood-Bank
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.