FDA.reportPublic FDA data

Personal Alarm

Primary DI
00616784708225
Brand
Personal Alarm
Company
Dynarex Corporation
Model
7082
Device description
Personal Alarm
Published
2021-05-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNJBed, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNJBed, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784708232PackageGS110In Commercial Distribution
00616784708225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784708232006167847082326167847082320616784708232
00616784708225006167847082256167847082250616784708225

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitor remote controlA hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of a patient monitor from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the patient or healthcare provider.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117352124AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67212019-11-25
00840117352148AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67222019-11-25
00840117352162AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67232019-11-25
00840117352186AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67242019-11-25
00616784894027LabChoice SecureSafety Safety Blood Collection Sets, Sterile,89402018-05-26
00616784894126LabChoice SecureSafety Safety Blood Collection Sets, Sterile89412018-05-26
00616784894225LabChoice SecureSafety Safety Blood Collection Sets, Sterile89422018-05-26
00616784010014Aluminum Crutches - Child101002019-09-30
00840117346505PA Safety Lancets, Pressure Activated, 21 G Needle71132026-06-01
00840117343788Dynacare HerCare Necessities Complete Kit13752026-05-29
00616784213132Shoe Cover Non-Conductive, Universal21312021-06-21
00616784213231Shoe Cover Non-Conductive, Non-Skid, Universal Size21322021-06-21
00616784213439Shoe Cover Non-Conductive, Non-Skid, X-Large21342021-06-21
00616784426518IV Pole Kit For Enteral Irrigation, Non-Sterile42652021-09-01
00616784562018DynaLift Transport Unit, White, 40" x 80" (101.6 cm x 203.2 cm)56202021-04-22
00616784562117DynaLift Transport Unit, Black, 40" x 80" (101.6 cm x 203.2 cm)56212021-04-22
00840117308992Resp-O2 Single Suction Catheter, 12 FR320032022-05-10
00840117309012Resp-O2 Single Suction Catheter, 14 FR320042022-05-10
00840117309036Resp-O2 Single Suction Catheter, 16 FR320052022-05-10
00840117309050Resp-O2 Single Suction Catheter, 18 FR320062022-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
34895262521519HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521471HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521488HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521495HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521501HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521518HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521525HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521532HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
06975575170189YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
06975575170196YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
06975575170202YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
05060631840548SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-21
05060631840005SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840012VoyagerSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840029Voyager CompactSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840500SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840517SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840760Safespace Hi-Lo CompartmentSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840524SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840531SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631843006Safespace on platform 19cmSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
50606318404940SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-10
00766923348109Stay Safe BedPEDICRAFT, INC.FNJ2025-07-21
00766923348123Stay SafePEDICRAFT, INC.FNJ2025-07-21
00845699005437SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005444SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005451SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005468SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005475SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005482SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30