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Nomad PMU800 Portable Recorder (USB)

FDA UDI

Class II (US FDA UDI)

by Neurotronics, LLC

Identity

Trade Name
Nomad PMU800 Portable Recorder (USB) FDA UDI
Generic Name
Home-use sleep apnoea recording system FDA UDI
Device Name
Nomad PMU800 Portable Recorder (USB) FDA UDI
Model / Reference
PMU800 FDA UDI
Description
Nomad PMU800 Portable Recorder (USB) FDA UDI

Identifiers

Catalog Number
N11133 FDA UDI
Primary DI / UDI-DI
00817111021141 FDA UDI
FDA Product Code
DQA FDA UDI
MNR FDA UDI
GWL FDA UDI
GMDN Term
Home-use sleep apnoea recording system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 FDA UDI
868.2375 FDA UDI
882.1835 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Home-use sleep apnoea recording system

Nomad PMU800 Portable Recorder (USB) by Neurotronics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home-use sleep apnoea recording system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurotronics, LLC

Sources (1)

  • FDA UDI a0c9435e-b342-4641-9fb9-570756fa38f2 34 fields · synced May 30, 2026