Care-E-Vac 3

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K062610

by Ohio Medical Corporation

Identity

Trade Name: CARE-E-VAC 3 FDA UDI
Generic Name: Emergency airway clearance suction system, electric FDA UDI
Device Name: Portable Suction Pump FDA UDI
Model / Reference: CARE-E-VAC 3 FDA UDI
Description: Portable Suction Pump FDA UDI

Identifiers

Primary DI / UDI-DI: 08688250002436 FDA UDI
510(k) Number: K062610 FDA 510(k)FDA UDI
FDA Product Code: BTA FDA 510(k)FDA UDI
GMDN Term: Emergency airway clearance suction system, electric FDA UDI

Classification

Device Class: Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 878.4780 FDA 510(k)
Regulation Number: 878.4780 FDA 510(k)FDA UDI
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

The Care-E-Vac 3 is a portable, powered aspiration pump classified as a medical device under device class 2. It is designed to suction fluids or foreign bodies from a patient and is substantially equivalent to a legally marketed predicate device.

The device may be powered by a 120 VAC outlet or a 12 VDC source and is supplied as a reusable unit. It is intended for use in clinical settings such as hospital code carts and patient transport, with no stated sterility, single-use designation, MRI safety, storage conditions, or additional authorisations beyond FDA 510(k) clearance under K062610.

Frequently asked questions

What is the Care-E-Vac 3 used for?

The Care-E-Vac 3 is designed to suction fluids or foreign bodies from a patient, making it suitable for use in clinical environments such as hospital code carts and patient transport where aspiration is needed.

How is the Care-E-Vac 3 powered and supplied?

The device can be powered by either a 120 VAC outlet or a 12 VDC source and is supplied as a reusable unit, meaning it is intended for multiple uses after appropriate cleaning and maintenance.

Is the Care-E-Vac 3 sterile or single-use?

The Care-E-Vac 3 is not designated as sterile or single-use; it is supplied as a reusable unit, so users must follow established cleaning and disinfection protocols between uses.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ohio Medical care-e-vac 3 Operator And Maintenance Manual, PDF 550542 care-e-vac3 manual R3, Ohio Medical care-e-vac®3 Manual + AI Chat & PDF | Manualzz, Ohio Medical 758000 CAREVAC 3 Portable Suction Aspirator

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K062610	Class II	Active

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Manufacturer

Manufacturer: Ohio Medical Corporation

Sources (2)

FDA 510(k) K062610 24 fields · synced Sep 25, 2026
FDA UDI df30f40c-04b1-42d1-8e1e-2114e1543580 36 fields · synced May 26, 2026