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Engage Medical Device Alarm Notification System (EMDAN)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Engage Medical Device Alarm Notification System (EMDAN) FDA UDI
- Generic Name
- Alarm application software FDA UDI
- Model / Reference
- EMDAN 2.3.1 FDA UDI
Identifiers
- Catalog Number
- 910-01957 FDA UDI
- Primary DI / UDI-DI
- 00860002177786 FDA UDI
- 510(k) Number
- K130339 FDA UDI
- FDA Product Code
- MSX FDA UDI
- GMDN Term
- Alarm application software 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Alarm application software
Engage Medical Device Alarm Notification System (EMDAN) by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alarm application software.
- Messenger — SPOK INC. · Class II
- Ascom — Ascom Sweden AB · Class II
- Ascom — Ascom Sweden AB · Class II
- CommonPath Enterprise — Critical Alert · Class II
- Cerner CareAware Event Management — Cerner Corporation · Class II
- Messenger — SPOK INC. · Class II
- Messenger — SPOK INC. · Class II
- Messenger — SPOK INC. · Class II
Cleared under the same submission
K130339 also covers:
- Engage Medical Device Alarm Notification System (EMDAN) — Stryker Corp.
- Engage Medical Device Alarm Notification System (EMDAN) — Stryker Corp.
- Engage Medical Device Alarm Notification System (EMDAN) — Stryker Corp.
- Engage Medical Device Alarm Notification System (EMDAN) — Stryker Corp.
- Engage Medical Device Alarm Notification System (EMDAN) — Stryker Corp.
- Engage Medical Device Alarm Notification System (EMDAN) — Stryker Corp.
- Engage Medical Device Alarm Notification System (EMDAN) — Stryker Corp.
- Engage Medical Device Alert Notification System (EMDAN) — Stryker Corp.
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
- Stryker Corp.
Sources (1)
- FDA UDI b7ad2199-dad6-4743-8823-66f935075cd6 34 fields · synced Jun 8, 2026