Identity
- Trade Name
- Separation Chamber Holder FDA UDI
- Generic Name
- Blood centrifugation system containment kit FDA UDI
- Model / Reference
- Separation Chamber Holder FDA UDI
Identifiers
- Catalog Number
- 6033 FDA UDI
- Primary DI / UDI-DI
- 07640125650457 FDA UDI
- FDA Product Code
- JQC FDA UDI
- GMDN Term
- Blood centrifugation system containment kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood centrifugation system containment kit
Separation Chamber Holder by Biosafe S.A. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood centrifugation system containment kit.
- Thermogenesis Start Up Accessory Kit, MarrowXpress — Thermogenesis Corp. · Class I
- PrepaCyte-CB 500 — CRYO-CELL INTERNATIONAL, INC. · Class II
- PXP-LAVARE — Thermogenesis Corp. · Class II
- Corning — CORNING INCORPORATED · Class I
- PXP-LAVARE — Thermogenesis Corp. · Class II
- X-WASH — Thermogenesis Corp. · Class I
- X-LAB — Thermogenesis Corp. · Class I
- PrepaCyte-CB — CRYO-CELL INTERNATIONAL, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biosafe S.A.
Sources (1)
- FDA UDI a2fc33d7-8171-4d4a-aacd-8e539e6608ea 34 fields · synced Jun 1, 2026