← Back to catalogue

OmniPro System

FDA UDI

Class II (US FDA UDI)

by Mays & Asscoiates

Identity

Trade Name
OmniPro System FDA UDI
Generic Name
Polysomnograph FDA UDI
Device Name
The OmniAmp is an amplifier system for use in polysomnogram (PSG) studies in a hospital or diagnostic center. FDA UDI
Model / Reference
OmniAmp PSG Module FDA UDI
Description
The OmniAmp is an amplifier system for use in polysomnogram (PSG) studies in a hospital or diagnostic center. FDA UDI

Identifiers

Catalog Number
360-8400 FDA UDI
Primary DI / UDI-DI
B62536084000 FDA UDI
510(k) Number
K050143 FDA UDI
FDA Product Code
OLV FDA UDI
GMDN Term
Polysomnograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1400 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Height — 3.8 Centimeter FDA UDI
Width — 15.5 Centimeter FDA UDI
Length — 20.5 Centimeter FDA UDI
Weight — 675 Gram FDA UDI

Category: Polysomnograph

OmniPro System by Mays & Asscoiates — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polysomnograph.

Cleared under the same submission

K050143 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mays & Asscoiates

Sources (1)

  • FDA UDI 6891bc5b-7328-4f28-aeb5-15623378ea93 37 fields · synced May 30, 2026