FDA UDI
In Commercial Distribution
🇺🇸 United States
LT Kit for PRP
DI: 06974621793013
·
Model: PRP-B11
·
Zhuhai Longtime Biological Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- LT Kit for PRP
- Primary DI
- 06974621793013
- Version / Model
- PRP-B11
- Company Name
- Zhuhai Longtime Biological Technology Co., Ltd
- Labeler DUNS
- 708328288
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-05
- Public Version
- 1
- Public Version Date
- 2023-06-13
- Public Version Status
- New
- Public Device Record Key
- 09e3fa5c-31aa-4187-975b-b3b643acdd3c
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GIO | Tube, Collection, Capillary Blood | Hematology | 864.6150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46923 | Haematological concentrate system preparation kit, platelet concentration | A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16974621793010 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 06974621793013 | GS1 | ||||
| Package | 56974621793018 | GS1 | Case | 40 | In Commercial Distribution |