FDA UDI
In Commercial Distribution
🇺🇸 United States
Sepax 2
DI: 07640125650587
·
Model: Sepax 2 S-100
·
Biosafe S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Sepax 2
- Primary DI
- 07640125650587
- Version / Model
- Sepax 2 S-100
- Catalog Number
- 14000
- Company Name
- Biosafe S.A.
- Labeler DUNS
- 488052341
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-18
- Public Version
- 3
- Public Version Date
- 2022-03-09
- Public Version Status
- Update
- Public Device Record Key
- db55d475-a8f0-4a89-8bd9-0c23cbd86fdc
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OAO | Cord Blood Processing System And Storage Container | Hematology | 864.9900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60334 | Blood centrifugation system processing unit | A mains electricity (AC-powered) portable device that is a component of a blood centrifugation system designed for the automated processing of blood, relative components or cellular products (e.g., umbilical cord blood, bone marrow), in a closed sterile environment using centrifugation to isolate constituent components (e.g., cells, plasma). It is a programmable device with an integral centrifuge intended to provide centrifugal and axial displacement drive to a centrifugation chamber, as well as drive to directional valves that control the flow of blood components to collection bags. The device is not donor or patient connected. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640125650587 | GS1 |
Customer Contacts
- Phone
- +41848802810
- [email protected]