FDA.reportPublic FDA data

RESPONDER 5, INTERACTIVE

Primary DI
00840828197076
Brand
RESPONDER 5, INTERACTIVE
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
5I4125U-162443A
Catalog number
30970
Device description
RESPONDER 5, INTERACTIVE
Published
2026-10-15
Public version status
New
Distribution status
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
ILQSystem, Communication, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840828197076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828197076008408281970768408281970760840828197076

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
00840828197021GEN4 INTERACTIVE418430U-0104029309322026-10-15
00840828197038GEN4 INTERACTIVE418430U-0637009309332026-10-15
00840828197052GEN4 INTERACTIVE433383U-0134008309482026-10-15
00840828197069US MATT PAD-UNI-CONNECT-NO LOGOCSP-US-U10-NL309552026-10-15
00840828197083RESPONDER 5, INTERACTIVE5I4128U-101023A309622026-10-15
00840828197090GEN4 INTERACTIVE439331U-0142018309652026-10-15
00840828197106GEN4 DIRECT ACCESSDARPSV-5007309432026-10-15
00840828197113GEN4 INTERACTIVE42521VU-0736018309522026-10-15
00840828197137GEN4 INTERACTIVE4G19TU-0131008310012026-10-15
00840828197144MBA-BE,S37,INL,1'BCC-5801-A01307882026-10-15
00840828197151MBA-BE,S37,INL,6'BCC-5801-A06307892026-10-15
00840828197168MBA-BE,P37,INL,1'BCC-5801-E01307902026-10-15
00840828197175MBA-BE,P37,INL,6'BCC-5801-E06307912026-10-15
00840828197182MBA-WE,P37,INL,1',DPBCC-5802-A01-001307922026-10-15
00840828197199MBA-WE,P37,INL,6',DPBCC-5802-A06-001307932026-10-15
00840828197205MBA-WE,P37(90),1',DPBCC-5803-A01-001307942026-10-15
00840828197212MBA-WE,P37(90),6',DPBCC-5803-A06-001307952026-10-15
00840828197229GEN4 INTERACTIVE4M190E-Z700038310062026-10-15
00840828197236GEN4 INTERACTIVE439430U-0143009310452026-10-15
00840828197243GEN4 INTERACTIVE439010N-0500018309662026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816486021589Via™ Pro 11PRENTKE ROMICH COMPANYILQ2026-10-21
00816486021602Genesis™ 13PRENTKE ROMICH COMPANYILQ2026-10-21
00816486021619Genesis™ 16PRENTKE ROMICH COMPANYILQ2026-10-21
00816486021664Genesis Eye Tracker™PRENTKE ROMICH COMPANYILQ2026-10-21
00816486021671Genesis™ 13 CHG EXTPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021688Genesis™ 16 CHG EXTPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021763Genesis™ 13 144 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021770Genesis™ 13 45 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021787Genesis™ 13 60 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021794Genesis™ 13 84 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021800Genesis™ 13 15 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021817Genesis™ 13 28 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021824Genesis™ 13 36 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021831Genesis™ 13 8 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021848Genesis™ 13 15 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021855Genesis™ 13 28 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021862Genesis™ 13 36 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021879Genesis™ 13 45 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021886Genesis™ 13 60 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021893Genesis™ 13 8 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021909Genesis™ 13 84 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021916Genesis™ 13 144 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021923Genesis™ 16 144 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021930Genesis™ 16 45 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021947Genesis™ 16 60 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021954Genesis™ 16 84 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021961Genesis™ 16 15 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021978Genesis™ 16 28 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021985Genesis™ 16 36 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021992Genesis™ 16 8 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21