FDA UDI
In Commercial Distribution
🇺🇸 United States
XCELL
DI: B708XCPSPC1200
·
Model: XC-PSPC-120
·
APEX BIOLOGIX , LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- XCELL
- Primary DI
- B708XCPSPC1200
- Version / Model
- XC-PSPC-120
- Company Name
- APEX BIOLOGIX , LLC
- Labeler DUNS
- 079560357
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-16
- Public Version
- 1
- Public Version Date
- 2022-11-24
- Public Version Status
- New
- Public Device Record Key
- 716d2ecb-d436-4c0e-8c39-ccb11436d4f4
Device Description
XCELL PC Fluid Volume Reducer 120ml XC-PSPC-120
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JJH | Clinical Sample Concentrator | Clinical Chemistry | 862.2310 | 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 | B708XCPSPC1201 | HIBCC | Case | 10 | In Commercial Distribution | |
| Primary | B708XCPSPC1200 | HIBCC | ||||
| Package | B708XCPSPC1202 | HIBCC | Shipper | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- 844-897-4910
- [email protected]