FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HARVEST®
DI: 05020583514065
·
Model: 51406
·
TERUMO BCT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HARVEST®
- Primary DI
- 05020583514065
- Version / Model
- 51406
- Company Name
- TERUMO BCT, INC.
- Labeler DUNS
- 801679200
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 11
- Public Version Date
- 2024-02-08
- Public Version Status
- Update
- Public Device Record Key
- 605e0e3c-585d-4411-b9e2-e56fae42c8f2
- Distribution End Date
- 2023-11-15
Device Description
Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-60 Procedure Pack
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| ORG | Platelet and plasma separator for bone graft handling | Hematology | 864.9245 | 2 |
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 |
|---|---|---|---|---|---|---|
| Primary | 05020583514065 | GS1 | ||||
| Package | 35020583514066 | GS1 | 3 | Not in Commercial Distribution | 2023-02-14 |
Customer Contacts
- Phone
- +1(877)339-4228
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius