FDA.reportPublic FDA data

REGO HUB,WEST-CALL NOVUS,NC, P

Primary DI
00840828180542
Brand
REGO HUB,WEST-CALL NOVUS,NC, P
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
HB01-24101002022
Catalog number
26221
Device description
REGO HUB,WEST-CALL NOVUS,NC, P
Published
2020-08-07
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
00840828180542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828180542008408281805428408281805420840828180542

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
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
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
00812324010586Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010593Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13