Identity
- Trade Name
- LATITUDE® FDA UDI
- Generic Name
- Patient health record information system application software FDA UDI
- Device Name
- Patient Management System FDA UDI
- Model / Reference
- 6488 FDA UDI
- Description
- Patient Management System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00802526562112 FDA UDI
- PMA Number
- P910077 FDA UDI
- FDA Product Code
- LWS FDA UDI
- GMDN Term
- Patient health record information system application software FDA UDI
Classification
- Device Class
- Class III 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: Patient health record information system application software
Latitude® by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P910077 also covers:
- LATITUDE Consult ™ Power Supply — Boston Scientific
- LATITUDE Consult™ — Boston Scientific
- LATITUDE Consult™ — Boston Scientific
- LATITUDE Consult™ — Boston Scientific
- LATITUDE Consult™ — Boston Scientific
- LATITUDE® — Boston Scientific
- LATITUDE® Communicator — Boston Scientific
- LATITUDE® Communicator — Boston Scientific
- LATITUDE® Communicator — Boston Scientific
- LATITUDE® Communicator — Boston Scientific
- LATITUDE® Communicator — Boston Scientific
- LATITUDE® Communicator — Boston Scientific
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 III | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 0a76d8bc-53b7-4318-8c64-446b959e6951 34 fields · synced May 30, 2026