FDA.reportPublic FDA data

PA-1

Primary DI
G395PA11
Brand
PA-1
Company
Med Labs Inc
Model
PA-1
Device description
Portable AlarmSystem communication . powered
Published
2023-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
G395PA11PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nurse call system alarmAn electronic device intended to provide an audible sound and/or a visual display, typically coloured flashing lights or scrolling text, to notify a medical professional that (urgent) assistance is needed by a patient. It may be in the form of dome lights, basic visual display screens, and/or beeping devices which are triggered by manual or automatic alert activators (e.g., bedside push-button, ambulatory fall sensor, bed occupancy sensor) [not included]; it may function independently or as a component of a nurse call system via the healthcare facility hardwired or wireless network.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
805-968-2486sales@medlabsinc.com

Regulatory Flags#

DUNS number
620223529
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G395EMS1C1EMS-1CEMS-1C2023-07-12
G395EMS2C1EMS-2CEMS-2C2023-07-12
G395EZCALL1E-Z CALLE-Z Call2023-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828197076RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-10-15
00840828197083RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-10-15
00840828197250RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-10-15
00850091787454CommonPath Nurse CallCritical AlertILQ2026-10-12
00850091787461CommonPath 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