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Resp-O2 50 PSI Compressor

FDA UDI

Class II (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name
Resp-O2 50 PSI Compressor FDA UDI
Generic Name
Medical device air compressor FDA UDI
Device Name
Voltage: AC 110-120V 60Hz, Max pressure: 95 psi (preset), Air flow at 0 psi: ~37 l/min, Air flow at 50 psi: ~17 l/min FDA UDI
Model / Reference
33952 FDA UDI
Description
Voltage: AC 110-120V 60Hz, Max pressure: 95 psi (preset), Air flow at 0 psi: ~37 l/min, Air flow at 50 psi: ~17 l/min FDA UDI

Identifiers

Primary DI / UDI-DI
00840117324008 FDA UDI
510(k) Number
K072634 FDA UDI
FDA Product Code
BTI FDA UDI
GMDN Term
Medical device air compressor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.6250 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

No

FDA UDI

Category: Medical device air compressor

Resp-O2 50 PSI Compressor by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical device air compressor.

Cleared under the same submission

K072634 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dynarex Corp.

Sources (1)

  • FDA UDI ff1fa7bd-a1f5-42dd-a909-639d3831a104 34 fields · synced May 30, 2026