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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