Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- Welch Allyn Connex Integrated Wall System with Masimo SpO2, SureTemp Plus Thermometry, Braun ThermoScan PRO 4000 Thermometry, BP Cuff and Cord Management System, Integrated MacroView Otoscope and Coaxial Ophthalmoscope, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, F FDA UDI
- Model / Reference
- 901028 FDA UDI
- Description
- Welch Allyn Connex Integrated Wall System with Masimo SpO2, SureTemp Plus Thermometry, Braun ThermoScan PRO 4000 Thermometry, BP Cuff and Cord Management System, Integrated MacroView Otoscope and Coaxial Ophthalmoscope, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, F FDA UDI
Identifiers
- Catalog Number
- 85MTVEC-B FDA UDI
- Primary DI / UDI-DI
- 00732094118964 FDA UDI
- 510(k) Number
- K112687 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple vital physiological parameter monitoring system, clinical
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112687 also covers:
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
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
- Welch Allyn, Inc.
Sources (1)
- FDA UDI f5014083-31cf-41d6-8dc9-9f3686a58067 36 fields · synced May 30, 2026