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Roscoe Medical

FDA UDI

Class II (US FDA UDI)

by Compass Health Brands Corp.

Identity

Trade Name
Roscoe Medical FDA UDI
Generic Name
Emergency airway clearance suction system, electric FDA UDI
Device Name
truAIRE PORTABLE ASPIRATOR SYSTEM W/ CARRY BAG & LI-ION BATTERY SYSTEM FDA UDI
Model / Reference
ASP-ROSP FDA UDI
Description
truAIRE PORTABLE ASPIRATOR SYSTEM W/ CARRY BAG & LI-ION BATTERY SYSTEM FDA UDI

Identifiers

Primary DI / UDI-DI
00092237626672 FDA UDI
510(k) Number
K063448 FDA UDI
FDA Product Code
CAH FDA UDI
JCX FDA UDI
GMDN Term
Emergency airway clearance suction system, electric FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5260 FDA UDI
878.4780 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

Similar devices

Also classified as Emergency airway clearance suction system, electric.

Cleared under the same submission

K063448 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Compass Health Brands Corp.

Sources (1)

  • FDA UDI 965b3d09-df6d-44f0-9898-6b38d26601e6 35 fields · synced Jun 8, 2026