DonorCare® Needle Guard Large Channel
DonorCare® Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
3manufacturers in China registered for this device type
1catalogue number
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 | ITL Asia Pacific SDN BHD, Malaysia |
|---|---|
| FDA product code | KSS |
| Device type | Supplies, Blood-Bank |
| Device class | Class 1 |
| Regulation | 21 CFR 864.9050 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | BK980008 |
| Record published | 2020-09-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry; Special storage condition: Keep Away from Direct Sunlight |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| A100150 | 1,000 | In distribution |
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| Capture-P | Immucor, Inc. | 3 |
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| Typesafe 2.0 | Typenex Medical, LLC | 2 |
| Capture-P Indicator Red Cells | Immucor, Inc. | 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.