FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LT Tube for PRP
DI: 06974621793365
·
Model: PRP25
·
Zhuhai Longtime Biological Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- LT Tube for PRP
- Primary DI
- 06974621793365
- Version / Model
- PRP25
- Company Name
- Zhuhai Longtime Biological Technology Co., Ltd
- Labeler DUNS
- 708328288
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-06
- Public Version
- 2
- Public Version Date
- 2026-04-02
- Public Version Status
- Update
- Public Device Record Key
- 4258de11-c3e4-42bf-ad28-41425802ca75
- Distribution End Date
- 2025-06-10
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| 47183 | Haematological concentrate system | An assembly of devices typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm), from a small volume of a patient's own blood/bone marrow for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). It typically consists of a centrifuge, a dedicated centrifuge tube(s) and sample collection/processing kits, a concentrate delivery unit, and various disposable applicators. After processing, the concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974621793365 | GS1 | ||||
| Package | 16974621793362 | GS1 | box | 1 | Not in Commercial Distribution | 2025-06-06 |
| Package | 56974621793360 | GS1 | case | 10 | Not in Commercial Distribution | 2025-06-06 |