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

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00616784317021Cotton Balls, Medium31702026-10-01
00616784671628SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrou67162026-09-30
00616784671727SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67172026-09-30
00616784671826SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67182026-09-30
00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67192026-09-30
00840117346147Resp-O2 M24 Oxygen E-Cylinder, With CGA 870 Toggle Valve, 4.55 L36390-TBULK2026-09-28
00840117346154Resp-O2 M15 Oxygen Standard D-Cylinder, With CGA 870 Toggle Valve36391-TBULK2026-09-28
00840117346239Resp-O2 M15 Oxygen Standard D-Cylinder, With CGA 870 Post Valve36391-PBULK2026-09-28
00840117320987Resp-O2 Suction Canister Rings, Compatible With 800 cc and 1200 cc Canister324092026-09-25
00840117352735dmecare Solutions Folding Beside Commode103702021-04-22
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00840117308855Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL342212022-05-11
00616784431321Junior Tongue Depressors, 5 1/2" (14.0 cm)43132021-09-01

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