FDA.reportPublic FDA data

GEN4 DIGITAL

Primary DI
00840828108836
Brand
GEN4 DIGITAL
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
4D050U-Z104188
Catalog number
2136
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQASystem, Environmental Control, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840828108836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828108836008408281088368408281088360840828108836

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-235-7500mwinter@curbell.com

Regulatory Flags#

DUNS number
796452311
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840828196444GEN4 INTERACTIVE421384U-0709008307402026-05-19
00840828196451GEN4 PLUS, DIRECT ACCESS5C050U-P10000288307442026-05-19
00840828196406GEN4 INTERACTIVE42119CU-0104018307102026-05-07
00840828196413GEN4 PLUS, DIRECT ACCESS5C330U-Z10300011307092026-05-07
00840828196420800 S37,JE,BE,2L,790,BE ON 6&8BIC-19C0-A08-8307022026-05-07
00840828196437GEN4 INTERACTIVE437370U-0119728307152026-05-07
00840828196369GEN4 INTERACTIVE45331E-S14059F306952026-04-23
00840828196376GEN4 INTERACTIVE43719FU-0103018307002026-04-23
00840828196383GEN4 PLUS, DIRECT ACCESS5C430U-Z3020000F307012026-04-23
00840828196390GEN4 PLUS, DIRECT ACCESS5C422U-Z12700028307062026-04-23
00840828196338CALLCD,800,180,NO LOGO,WIRED FOR CACC180-986306882026-04-14
00840828196345RESPONDER 5, INTERACTIVE5I41JU-562427A306892026-04-14
00840828196352RESPONDER 5, INTERACTIVE5I41UU-801002A306922026-04-14
00840828196321SURELOCK, CURBELL/PHILIPS, BLUE, 10 PK989803209691306232026-04-09
00840828196284GEN4 INTERACTIVE410370E-0104468306862026-04-08
00840828196291BED COVER-4X36X88-CEN PRO PLUS MAT TOP-PBMC-43688-CENPROPLUSTOP-PC306852026-04-08
00840828196246RESPONDER 5, INTERACTIVE5I414U-164031A306742026-04-01
00840828196253GEN4 INTERACTIVE45422U-S103028306802026-04-01
00840828196260GEN4 PLUS, DIRECT ACCESS5C19DU-Z15900178306762026-04-01
00840828196277GEN4 INTERACTIVE425331U-0150518306512026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196444GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-19
00840828196451GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-05-19
00840828196406GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-07
00840828196413GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-05-07
00840828196437GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-07
00840828196369GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-04-23
00840828196376GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-04-23
00840828196383GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-04-23
00840828196390GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-04-23
00840828196284GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-04-08
00840828196253GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-04-01
00840828196260GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-04-01
00840828196277GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-04-01
00840828196222GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-03-26
00840828196239GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-03-26
00840828196178"JUMPER,6"",S102 TO 7 PIN DIN"CURBELL 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