FDA.reportPublic FDA data

CommonPath Nurse Call

Primary DI
00850091787461
Brand
CommonPath Nurse Call
Company
Critical Alert
Model
IRB-5501
Device description
Infrared staff badge, green, Level 1, 5500 series, 56 KHz. Badge color indicates the level.
Published
2026-10-12
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

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
00850091787461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850091787461008500917874618500917874610850091787461

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
112008769
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
00850091787454CommonPath Nurse CallIRB-55002026-10-12
00850091787478CommonPath Nurse CallIRB-55022026-10-12
00850091787485CommonPath Nurse CallIRB-55032026-10-12
00850091787492CommonPath Nurse CallIRB-32002026-10-12
00850091787508CommonPath Nurse CallIRB-32012026-10-12
00850091787515CommonPath Nurse CallIRB-32022026-10-12
00850091787522CommonPath Nurse CallIRB-32032026-10-12
00850091787539CommonPath Nurse CallRCR-50002026-10-12
00850091787546CommonPath Nurse CallRFP-53422026-10-12
00850091787553CommonPath Nurse CallRMR-50042026-10-12
00850091787560CommonPath Nurse CallBed Connector Kit Family2026-10-12
00850091787577CommonPath Nurse CallIJACK-50002026-10-12
00860006582012TigerConnect Alarm Management2026-05-29
00860006582005CommonPath Enterprise2021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850091787454CommonPath Nurse CallCritical AlertILQ2026-10-12
00850091787478CommonPath Nurse CallCritical AlertILQ2026-10-12
00850091787485CommonPath Nurse CallCritical AlertILQ2026-10-12
00850091787492CommonPath Nurse CallCritical AlertILQ2026-10-12
00850091787508CommonPath Nurse CallCritical AlertILQ2026-10-12
00850091787515CommonPath Nurse CallCritical AlertILQ2026-10-12
00850091787522CommonPath Nurse CallCritical AlertILQ2026-10-12
00850091787539CommonPath Nurse CallCritical AlertILQ2026-10-12
00850091787546CommonPath Nurse CallCritical AlertILQ2026-10-12
00850091787553CommonPath Nurse CallCritical AlertILQ2026-10-12
00850091787560CommonPath Nurse CallCritical AlertILQ2026-10-12
00850091787577CommonPath Nurse CallCritical AlertILQ2026-10-12
00812324018315Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018322Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018339Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018346Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018353Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018360Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018377Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018384Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018391Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018407Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018414Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018421Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018438Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018445Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018452Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018469Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018476Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018483Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30