FDA.report

DRIVEMEDICAL

Primary DI
50822383116346
Brand
DRIVEMEDICAL
Company
Drive Devilbiss Healthcare
Model
13601
Device description
Patient RoomPatient alarms Product Description: Bedside Alarm,Wireless,1/ea
Published
2019-06-21
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KMIMONITOR, BED PATIENT

Product Code Classifications

CodeDeviceSpecialtyClass
KMIMonitor, Bed PatientGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50822383116346PackageGS14Not in Commercial Distribution
00822383116341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5082238311634650822383116346
00822383116341008223831163418223831163410822383116341

GMDN Terms

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

Regulatory Flags

DUNS number
867673159
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

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