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Emergency Response System

FDA UDI

Class II (US FDA UDI)

by Nihon Kohden America, Inc.

Identity

Trade Name
Emergency Response System FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
Emergency response system for field deployable ED overflow needs FDA UDI
Model / Reference
A-WSS-001-ZA FDA UDI
Description
Emergency response system for field deployable ED overflow needs FDA UDI

Identifiers

Catalog Number
A-WSS-001-ZA FDA UDI
Primary DI / UDI-DI
00841983104190 FDA UDI
FDA Product Code
DRG FDA UDI
MHX FDA UDI
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2910 FDA UDI
870.1025 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

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

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 9d01b09b-9add-41f9-aee4-769ea250d1b0 36 fields · synced Jun 7, 2026