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STATVAC II Oxygen powered Aspirator

FDA UDI

Class II (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name
STATVAC II Oxygen powered Aspirator FDA UDI
Generic Name
Emergency airway clearance suction system, pneumatic FDA UDI
Device Name
The O-Two Statvac® II Aspirator is capable of effectively suctioning out excessive quantities of fluid/particles from a patient’s oro/naso pharynx. The lightweight aspirator is designed to be attached to any 50 psi DISS outlet. The ON/OFF shuttle provides for fast actuation of the aspirator in an emergency. Continuous suction is provided by simply depressing the “GREEN” shuttle control. The aspiration can be quickly and easily turned off by depressing the “RED” shuttle control button on the opposite side of the aspirator. FDA UDI
Model / Reference
01AS9502 FDA UDI
Description
The O-Two Statvac® II Aspirator is capable of effectively suctioning out excessive quantities of fluid/particles from a patient’s oro/naso pharynx. The lightweight aspirator is designed to be attached to any 50 psi DISS outlet. The ON/OFF shuttle provides for fast actuation of the aspirator in an emergency. Continuous suction is provided by simply depressing the “GREEN” shuttle control. The aspiration can be quickly and easily turned off by depressing the “RED” shuttle control button on the opposite side of the aspirator. FDA UDI

Identifiers

Catalog Number
01AS9502 FDA UDI
Primary DI / UDI-DI
07540195053038 FDA UDI
FDA Product Code
BTA FDA UDI
GMDN Term
Emergency airway clearance suction system, pneumatic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 12 Fluid Ounce FDA UDI

Category: Emergency airway clearance suction system, pneumatic

STATVAC II Oxygen powered Aspirator by O-Two Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Emergency airway clearance suction system, pneumatic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
O-Two Medical Technologies Inc

Sources (1)

  • FDA UDI 8aafe31f-57a2-423e-9e4e-5131df6f3fdc 37 fields · synced Jun 1, 2026