Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- Sk,Module Assy Spo2 Masimo Mx FDA UDI
- Model / Reference
- 901012 FDA UDI
- Description
- Sk,Module Assy Spo2 Masimo Mx FDA UDI
Identifiers
- Catalog Number
- 104290 FDA UDI
- Primary DI / UDI-DI
- 00732094062540 FDA UDI
- 510(k) Number
- K112687 FDA UDI
- FDA Product Code
- MWD FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical 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: Multiple vital physiological parameter monitoring system, clinical
Welch Allyn, Inc. by Welch Allyn, Inc. — Class III — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (1)
- FDA UDI cad65052-b36b-477b-85dc-38cbb07e2725 36 fields · synced Jun 1, 2026