Identity
- Trade Name
- Fisher & Paykel Healthcare FDA UDI
- Generic Name
- Configurable electronic form web-based application software FDA UDI
- Device Name
- Infosmart Web FDA UDI
- Model / Reference
- Infosmart_web FDA UDI
- Description
- Infosmart Web FDA UDI
Identifiers
- Catalog Number
- Infosmart_web FDA UDI
- Primary DI / UDI-DI
- 09420012448019 FDA UDI
- 510(k) Number
- K110316 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- Configurable electronic form web-based application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Configurable electronic form web-based application software
Fisher & Paykel Healthcare by Fisher & Paykel Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Configurable electronic form web-based application software.
- Donor Doc 3.x.x — GPI USA, INC. · Class II
- PharmGuard — ICU MEDICAL, INC. · Class I
- myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & Outcomes — FUTURE HEALTH WORKS LTD · Class I
- Donor-ID — HEALTHCARE-ID, INC. · Class II
- PharmGuard — ICU MEDICAL, INC. · Class I
- Relivion MG App — Neurolief , Ltd. · Class II
- Donor Doc — HAEMONETICS CORPORATION · Class II
- Donor-ID — HEALTHCARE-ID, INC. · Class II
Cleared under the same submission
K110316 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
- Fisher & Paykel Healthcare, Inc.
Sources (1)
- FDA UDI a72a1b5c-92a0-4ecf-9b5a-a58e92d06f65 35 fields · synced Jun 8, 2026