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NomadAir PMU810 RIP Belt, Medium

FDA UDI

Class II (US FDA UDI)

by Neurotronics, LLC

Identity

Trade Name
NomadAir PMU810 RIP Belt, Medium FDA UDI
Generic Name
Home-use sleep apnoea recording system FDA UDI
Model / Reference
PMU810 FDA UDI

Identifiers

Primary DI / UDI-DI
00817111021202 FDA UDI
510(k) Number
K220631 FDA UDI
FDA Product Code
MNR FDA UDI
GMDN Term
Home-use sleep apnoea recording system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 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

NomadAir PMU810 RIP Belt, Medium 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.

Cleared under the same submission

K220631 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurotronics, LLC

Sources (1)

  • FDA UDI 4a7bcfb0-8911-4b29-bf1b-ee1c9c30e100 33 fields · synced May 30, 2026