Identity
- Trade Name
- SoftID.Tx FDA UDI
- Generic Name
- Bedside information system application software FDA UDI
- Model / Reference
- 1.0.0.16 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859474006526 FDA UDI
- FDA Product Code
- MMH FDA UDI
- GMDN Term
- Bedside information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9165 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
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: Bedside information system application software
SoftID.Tx by Scc Soft Computer — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bedside information system application software.
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- Gateway Software Server VF9.1.2 — Draeger Medical Systems, Inc. · Class II
- Voalte SmartSync — HILL-ROM, INC. · Class I
- NaviCare® SmartSync Systems — HILL-ROM, INC. · Class I
- NaviCare® SmartSync Systems — HILL-ROM, INC. · Class I
Cleared under the same submission
BK090078 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scc Soft Computer
Sources (1)
- FDA UDI 77f0f8ee-ee13-4d12-b3ce-8da5c82af662 33 fields · synced May 31, 2026