Identity
- Trade Name
- Fenwal DXT Relay Release 2.2 FDA UDI
- Generic Name
- Blood bank information system application software FDA UDI
- Device Name
- Fenwal DXT Relay is a Microsoft WINDOWS-based software application intended to be used by trained blood center professionals to receive and transmit data between blood bank instruments (apheresis and nonapheresis) and Computer Systems. The data may also be stored in and accessed from Fenwal DXT Relay's database. FDA UDI
- Model / Reference
- 5S9803 FDA UDI
- Description
- Fenwal DXT Relay is a Microsoft WINDOWS-based software application intended to be used by trained blood center professionals to receive and transmit data between blood bank instruments (apheresis and nonapheresis) and Computer Systems. The data may also be stored in and accessed from Fenwal DXT Relay's database. FDA UDI
Identifiers
- Catalog Number
- 5S9803 FDA UDI
- Primary DI / UDI-DI
- 00811137013043 FDA UDI
- FDA Product Code
- MMH FDA UDIOUG FDA UDI
- GMDN Term
- Blood bank information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9165 FDA UDI880.6310 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical equipment clinical data interfacing softwareBlood bank information system application software
Fenwal DXT Relay Release 2.2 by Fenwal, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Fenwal, Inc.
Sources (1)
- FDA UDI eac0a2b7-8dc8-4150-9c63-9195430aadd7 34 fields · synced Jun 8, 2026