FDA UDI
In Commercial Distribution
🇺🇸 United States
Cervos Platelet Single BD
DI: 00850023741684
·
Model: CER-PRP-SINGLE-BD
·
RANFAC CORP.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Cervos Platelet Single BD
- Primary DI
- 00850023741684
- Version / Model
- CER-PRP-SINGLE-BD
- Catalog Number
- CER-PRP-SINGLE
- Company Name
- RANFAC CORP.
- Labeler DUNS
- 121622872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-02
- Public Version
- 2
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- 7e405da8-e1b8-4a14-af88-e2ef42dc05eb
Device Description
CER-PRP-SINGLE F/G, STERILE PN: 76129-01M
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
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 | 10850023741681 | GS1 | CASE | 12 | In Commercial Distribution | |
| Primary | 00850023741684 | GS1 |
Customer Contacts
- Phone
- 5085884400
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 40 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 77 Degrees Fahrenheit