FDA.reportPublic FDA data

Responder

Primary DI
00841492105688
Brand
Responder
Company
RAULAND-BORG CORPORATION
Model
R5KPD2AV2
Published
2025-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841492105685PackageGS11In Commercial Distribution
20841492105682PackageGS110In Commercial Distribution
00841492105688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084149210568510841492105685
2084149210568220841492105682
00841492105688008414921056888414921056880841492105688

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.

Regulatory Flags#

DUNS number
005105515
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
00841492105671ResponderR5KPC11WPV22025-06-24
00841492105695ResponderR5KPS1AV22025-06-24
00841492105701ResponderR5KPS1EAV22025-06-24
00841492105718ResponderR5KPS1LCAV22025-06-24
00841492105725ResponderR5KSDTYV22025-06-24
00841492105732ResponderR5KSMSTV22025-06-24
00841492105749ResponderR5KSSTFV22025-06-24
00841492105473ResponderR5KMTRMV22025-06-23
00841492105626ResponderR5KPB4CNFV22025-06-23
00841492105633ResponderR5KPB4V22025-06-23
10841492105470ResponderR5KMTRMV22025-06-23
10841492105623ResponderR5KPB4CNFV22025-06-23
10841492105630ResponderR5KPB4V22025-06-23
00841492101574ResponderR4KMQCV22025-06-20
00841492101628ResponderR4KPA252025-06-20
00841492105152Responder3744002025-06-20
00841492105206ResponderR5KMSCV22025-06-20
00841492105237Responder351003GSA2025-06-20
00841492105244ResponderR5KMPR15GSA2025-06-20
00841492105251ResponderR5KMPR36GSA2025-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28