Identity
- Trade Name
- Infinity M300 Masimo WPA2 FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Model / Reference
- MS26031 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049098002066 FDA UDI
- 510(k) Number
- K130711 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose multi-parameter bedside monitor
Infinity M300 Masimo WPA2 by Draeger Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130711 also covers:
- INFINITY M300 Nellcor WPA2 — Draeger Medical Systems, Inc.
- Infinity CentralStation Wide (confi) — Draeger Medical Systems, Inc.
- Infinity M300 PWT — Draeger Medical Systems, Inc.
- SW Options (confi) — Draeger Medical Systems, Inc.
- Ship Exc M300 Nellcor PWT — Draeger Medical Systems, Inc.
- Shp Exc M300 Masimo PWT — Draeger Medical Systems, Inc.
- Shp Unt Infinity Central Station — Draeger Medical Systems, 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
- Draeger Medical Systems, Inc.
Sources (1)
- FDA UDI 911815ec-de3d-4919-b9ad-0bc98a7ca52d 34 fields · synced Jun 9, 2026