FDA.reportPublic FDA data

REGO HUB,RAULAND R5,3FT-C,6FT-P,RELAYS

Primary DI
00840828173339
Brand
REGO HUB,RAULAND R5,3FT-C,6FT-P,RELAYS
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
HB01-90000101036
Catalog number
24690
Device description
REGO HUB,RAULAND R5,3FT-C,6FT-P,RELAYS
Published
2019-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840828173339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828173339008408281733398408281733390840828173339

GMDN Terms#

Term, Definition table
TermDefinition
Nurse call systemAn assembly of electronic devices, integrated within a facility infrastructure and/or wireless network, designed to provide an audio/visual signal to summon help when activated in response to a patient’s need for (urgent) assistance. It typically consists of and/or interacts with user- or sensor-activated signal transmitters (e.g., patient-worn pendant, push-buttons, microphones, speakers, fall sensors, smoke alarm, door sensors), a network communicator, and alert communication devices (e.g., server computer, phone, dome lights, audible alarm). The device notifies medical professionals and caregivers and is intended for use in the healthcare facility.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002357500mwinter@curbell.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840828196666GEN4 INTERACTIVE414331E-9143018308052026-06-09
00840828196673GEN4 INTERACTIVE438400N-0500018308032026-06-09
00840828196680RESPONDER 5, INTERACTIVE5I411U-165031A308082026-06-09
00840828196468RESPONDER 5, INTERACTIVE5I4112U-101463A307532026-05-27
00840828196475GEN4 INTERACTIVE412331U-0103018307602026-05-27
00840828196482GEN4 INTERACTIVE412331U-0105018307612026-05-27
00840828196499GEN4 INTERACTIVE412331U-0147018307622026-05-27
00840828196505GEN4 INTERACTIVE412331U-0147178307632026-05-27
00840828196512GEN4 INTERACTIVE412331U-0143018307642026-05-27
00840828196529GEN4 INTERACTIVE412331U-0147171307652026-05-27
00840828196536GEN4 INTERACTIVE412331U-0150018307662026-05-27
00840828196543GEN4 INTERACTIVE412331U-0145518307672026-05-27
00840828196550GEN4 INTERACTIVE412331U-0100008307682026-05-27
00840828196567GEN4 INTERACTIVE412331U-0100018307692026-05-27
00840828196574GEN4 INTERACTIVE412331U-0119018307702026-05-27
00840828196581GEN4 INTERACTIVE412331U-014701C307712026-05-27
00840828196598GEN4 INTERACTIVE412331U-0105011307722026-05-27
00840828196604GEN4 INTERACTIVE412331U-0153518307732026-05-27
00840828196611GEN4 INTERACTIVE412331U-015400C307742026-05-27
00840828196628GEN4 INTERACTIVE412331U-0155588307752026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196680RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-06-09
00840828196468RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-05-27
G783OSKOL20IrisbondIRISBOND CROWDBONDING SL.ILQ2025-08-01
00812324010319Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010326Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010333Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010340Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010357Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010364Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010371Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010388Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010395Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010401Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010418Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010425Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010432Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010449Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010456Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010463Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010470Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010487Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010494Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010500Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010517Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010524Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010531Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010548Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010555Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010562Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010579Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13