Identity
- Trade Name
- SEADUC FDA UDI
- Generic Name
- Emergency airway clearance suction pump, manual FDA UDI
- Device Name
- The first and only completely hand held manual suction device with the capability to perform the SALAD technique. Affordable, effective and simple to use, SEADUC™ provides instant readiness for resuscitation. FDA UDI
- Model / Reference
- EMI700 FDA UDI
- Description
- The first and only completely hand held manual suction device with the capability to perform the SALAD technique. Affordable, effective and simple to use, SEADUC™ provides instant readiness for resuscitation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007555336 FDA UDI
- 510(k) Number
- K882017 FDA UDI
- FDA Product Code
- BSY FDA UDI
- GMDN Term
- Emergency airway clearance suction pump, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Emergency airway clearance suction pump, manual
Seaduc by E.M. Innovations, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K882017 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- E.M. Innovations, Inc.
Sources (1)
- FDA UDI bf1deec0-0c10-4ffa-b463-8aa5a83c299b 35 fields · synced Jun 8, 2026