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Responder 5, Interactive

FDA UDI

Class II (US FDA UDI)

by Curbell Medical Products, Inc.

Identity

Trade Name
RESPONDER 5, INTERACTIVE FDA UDI
Generic Name
Pillow speaker FDA UDI
Device Name
RESPONDER 5, INTERACTIVE FDA UDI
Model / Reference
4I419U-101033A FDA UDI
Description
RESPONDER 5, INTERACTIVE FDA UDI

Identifiers

Catalog Number
19227 FDA UDI
Primary DI / UDI-DI
00840828143912 FDA UDI
FDA Product Code
ILQ FDA UDI
GMDN Term
Pillow speaker FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.3710 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pillow speaker

Responder 5, Interactive by Curbell Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pillow speaker.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Curbell Medical Products, Inc.

Sources (1)

  • FDA UDI 17d1b90a-3775-431b-8179-690ad9ac94e6 35 fields · synced May 29, 2026