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Polysmith Sleep System

FDA UDI

Class II (US FDA UDI)

by Nihon Kohden America, Inc.

Identity

Trade Name
Polysmith Sleep System FDA UDI
Generic Name
Sleep disorder interpretive software FDA UDI
Device Name
Polysomnography Sleep System Version 10 FDA UDI
Model / Reference
A/ONEBED-SCORE-10X FDA UDI
Description
Polysomnography Sleep System Version 10 FDA UDI

Identifiers

Catalog Number
A/ONEBED-SCORE-10X FDA UDI
Primary DI / UDI-DI
00841983103148 FDA UDI
FDA Product Code
OLV FDA UDI
OLT FDA UDI
GMDN Term
Sleep disorder interpretive software 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

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

No

FDA UDI

Category: Sleep disorder interpretive software

Polysmith Sleep System by Nihon Kohden America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sleep disorder interpretive software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nihon Kohden America, Inc.

Sources (1)

  • FDA UDI 28942639-2a6a-4c59-8b22-1c2f88657c2d 35 fields · synced Jun 7, 2026