FDA.report

GEN4 DIGITAL

Primary DI
00840828113335
Brand
GEN4 DIGITAL
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
4D360N-P102068
Catalog number
2596
Device description
GEN4 DIGITAL
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IQASystem, Environmental Control, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840828113335PrimaryGS10

GMDN Terms

TermDefinition
Pillow speakerA loudspeaker intended to be used by a patient when lying in bed or resting in a chair by putting it close to their ear or between a pillow and their ear. It is typically designed as a small pillow-like device that contains a loudspeaker and that has a cable and a connector for connection to a radio, television, or other sound-emitting device with a Jack plug sound outlet. The sound level is regulated by the user with an adjustable control. It is typically used to create a relaxing atmosphere with music, for entertainment (e.g., to listen to the radio), and to aid sleep and relieve tinnitus.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-235-7500mwinter@curbell.com

Regulatory Flags

DUNS number
796452311
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00840828196109GEN4 PLUS, DIRECT ACCESS5C383U-Z10300008306042026-03-11
00840828196116GEN4 INTERACTIVE4G331E-0148798305822026-03-11
00840828196123RESPONDER 5, INTERACTIVE5I4112U-B64453A306142026-03-11
00840828196130RESPONDER 5, INTERACTIVE5I4112U-101471A306052026-03-11
00840828196147RESPONDER 5, INTERACTIVE5I4112U-500001A306082026-03-11
00840828196154RESPONDER 5, INTERACTIVE5I411U-F00001A306112026-03-11
00840828196161GEN4 INTERACTIVE414430U-0151049306152026-03-11
00840828196079GEN4 DIRECT ACCESS4C19NN-Z10200A305452026-03-04
00840828196086GEN4 DIRECT ACCESS4C19NN-Z10200C305462026-03-04
00840828196093RESPONDER 5, INTERACTIVE5I4112U-001462A306012026-03-04
00840828196000GEN4 INTERACTIVE43319FU-0143088305712026-03-03
00840828196017GEN4 INTERACTIVE4X331E-000503C305812026-03-03
00840828196024RESPONDER 5, INTERACTIVE5I41JU-363465A305862026-03-03
00840828196031GEN4 INTERACTIVE414370E-010346A305932026-03-03
00840828196048RESPONDER 5, INTERACTIVE5I41JU-363425A305942026-03-03
00840828196055GEN4 INTERACTIVE4M370E-Z749368305962026-03-03
00840828196062GEN4 INTERACTIVE4M370E-Z749448305982026-03-03
00840828195966ZEPHYR,800,10,PUFF,JERON 680GEB-19C0-203A-N305512026-02-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840828196178JUMPER,6",S102 TO 7 PIN DINCURBELL MEDICAL PRODUCTS, INC.IQA2026-03-20
B484DARPSM50094A0Elite Digital Pillow Speaker for Critical Alert, 8-pin DIN, Nurse, PTW, BeepCrest Healthcare SupplyIQA2026-03-13
00840828196109GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-03-11
00840828196116GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-11
00840828196161GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-11
00840828196079GEN4 DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-03-04
00840828196086GEN4 DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-03-04
00840828196000GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-03
00840828196017GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-03
00840828196031GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-03
00840828196055GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-03
00840828196062GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-03-03
00840828195928GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-02-05
00840828195935GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-02-05
00840828195904GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-02-03
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