FDA.reportPublic FDA data

GEN4 INTERACTIVE

Primary DI
00840828131650
Brand
GEN4 INTERACTIVE
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
410370N-0903448
Catalog number
19724
Device description
GEN4 INTERACTIVE
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital
ILQSystem, Communication, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2
ILQSystem, Communication, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840828131650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828131650008408281316508408281316500840828131650

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
18002357500mwinter@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
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840828196178JUMPER,6",S102 TO 7 PIN DINJU06-626306542026-03-20
00840828187374SURE LOCK, ASSEMBLY, A34, BLUE LEVERSLC-4200-006277592023-01-09
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014667602MedMinder Systems, Inc.MEDMINDER SYSTEMS, INC.ILQ2026-03-23
06979878770084CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-03-17
06979878770091CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-03-17
06979878770107CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-03-17
06979878770114CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-03-17
00840828196123RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196130RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196147RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196154RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00816486021640PRC-SaltilloPRENTKE ROMICH COMPANYILQ2026-03-10
00840828196093RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-04
00840828196024RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-03
00840828196048RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-03
00841447109754Invacare® Think Soft® Long Term Care Bed Positioning DeviceINVACARE CORPORATIONFNL2026-03-02
00815027012628DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONFNL2026-02-27
00815027012635DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONFNL2026-02-27
00815027012895DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONFNL2026-02-27
08592654577462Eleganza 5L I N E T spol. s r.o.FNL2026-02-26
08592654582992Eleganza 5L I N E T spol. s r.o.FNL2026-02-26
00840828195966ZEPHYR,800,10,PUFF,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195973ZEPHYR,800,10,SIP=N,PUFF=TV,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195980ZEPHYR,800,10,SIP=TV,PUFF=N,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195997ZEPHYR,800,10,SIP,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00369771005615GeriGentleEQJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNL2026-02-09
00840828195942GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.FNL2026-02-05
00840828195959GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.FNL2026-02-05
00840828189897102,103 P37,BE & NURSE,CUSTOM LABELINGCURBELL MEDICAL PRODUCTS, INC.FNL2023-08-01
008408281884323701 P37,1TO1,STND,72",ALT. THUMBSCREWSCURBELL MEDICAL PRODUCTS, INC.FNL2023-02-27
008408281872063701 P37, NO 2,3,16,19,27,28,29,36, 96"CURBELL MEDICAL PRODUCTS, INC.FNL2022-12-02
008408281872133701 P37, NO PINS 16,19,28,29,36, 96"CURBELL MEDICAL PRODUCTS, INC.FNL2022-12-02