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iNAP One

FDA UDI

Class II (US FDA UDI)

by Somnics, Inc.

Identity

Trade Name
iNAP One FDA UDI
Generic Name
Intraoral negative-pressure sleep apnoea unit FDA UDI
Device Name
R07-B, C07, T01, I07, A03*3, P01, ZeeBud FDA UDI
Model / Reference
Starter Kit FDA UDI
Description
R07-B, C07, T01, I07, A03*3, P01, ZeeBud FDA UDI

Identifiers

Primary DI / UDI-DI
04719878321099 FDA UDI
510(k) Number
K193460 FDA UDI
FDA Product Code
OZR 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
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: Intraoral negative-pressure sleep apnoea unit

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

Similar devices

Also classified as Intraoral negative-pressure sleep apnoea unit.

Cleared under the same submission

K193460 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Somnics, Inc.

Sources (1)

  • FDA UDI 259466b3-3e30-425d-aa26-30cffbca0c3e 35 fields · synced Jun 6, 2026