Identity
- Trade Name
- Voalte Patient Safety FDA UDI
- Generic Name
- Bedside information system application software FDA UDI
- Device Name
- Medical Software FDA UDI
- Model / Reference
- 4.0 FDA UDI
- Description
- Medical Software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887761995086 FDA UDI
- FDA Product Code
- KMI FDA UDI
- GMDN Term
- Bedside information system application software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.2400 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bedside information system application software
Voalte Patient Safety by Hill-Rom, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SoftID.Tx — SCC SOFT COMPUTER · Class II
- SoftID.Tx — SCC SOFT COMPUTER · Class II
- Gateway Software Server VF9.1.2 — Draeger Medical Systems, 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 |
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Manufacturer
- Manufacturer
- Hill-Rom, Inc.
Sources (1)
- FDA UDI 5c8f2834-798f-480c-b98c-718b16c05e13 34 fields · synced May 30, 2026