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iNAP

FDA UDI

Class II (US FDA UDI)

by Somnics, Inc.

Identity

Trade Name
iNAP FDA UDI
Generic Name
Intraoral negative-pressure sleep apnoea unit FDA UDI
Device Name
(1) iNAP One Sleep Therapy System [iNAP Console(R07-A) x1, Tubing Set x1, Saliva Container x1, Power Adapter x1, Oral Interface (Model: I07H) x1, DryPad x93]; (2) Nasal Dilator [ZEEBUD x1] FDA UDI
Model / Reference
Starter Kit FDA UDI
Description
(1) iNAP One Sleep Therapy System [iNAP Console(R07-A) x1, Tubing Set x1, Saliva Container x1, Power Adapter x1, Oral Interface (Model: I07H) x1, DryPad x93]; (2) Nasal Dilator [ZEEBUD x1] FDA UDI

Identifiers

Primary DI / UDI-DI
04719878321532 FDA UDI
FDA Product Code
OZR FDA UDI
LWF FDA UDI
GMDN Term
Intraoral negative-pressure sleep apnoea unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 FDA UDI
874.3900 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

Yes

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

Category: Intraoral negative-pressure sleep apnoea unitNasal breathing aid, internal, reusable

iNAP by Somnics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nasal breathing aid, internal, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Somnics, Inc.

Sources (1)

  • FDA UDI 8acb544e-dd05-43bc-9ad3-39a57fa086cb 34 fields · synced Jun 8, 2026