Identity
- Trade Name
- Roscoe Medical FDA UDI
- Generic Name
- Emergency airway clearance suction system, electric FDA UDI
- Device Name
- Bacteria Filter for ASP-ROSP FDA UDI
- Model / Reference
- X1PASP03 FDA UDI
- Description
- Bacteria Filter for ASP-ROSP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815067013609 FDA UDI
- 510(k) Number
- K063448 FDA UDI
- FDA Product Code
- CAH FDA UDIJCX FDA UDI
- GMDN Term
- Emergency airway clearance suction system, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 FDA UDI878.4780 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Emergency airway clearance suction system, electric
Roscoe Medical by Compass Health Brands Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Compass Health Brands Corp.
Sources (1)
- FDA UDI 33bc618d-e2d1-47eb-bd30-02cd5dfcb9f4 35 fields · synced May 30, 2026