FDA.report

COMM CABLE,STND,HRM 37P-EXE 7P(6&8,N,TV,R),IN-LINE

Primary DI
B4841033240
Brand
COMM CABLE,STND,HRM 37P-EXE 7P(6&8,N,TV,R),IN-LINE
Company
Crest Healthcare Supply
Model
103324
Device description
COMM CABLE,STND,HRM 37P-EXE 7P(6&8,N,TV,R),IN-LINE
Published
2017-08-30
Public version status
Update
Distribution status
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
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications

CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B4841033240PrimaryHIBCC0

GMDN Terms

TermDefinition
Nurse call systemAn assembly of electronic devices, integrated within a facility infrastructure and/or wireless network, designed to provide an audio/visual signal to summon help when activated in response to a patient’s need for (urgent) assistance. It typically consists of and/or interacts with user- or sensor-activated signal transmitters (e.g., patient-worn pendant, push-buttons, microphones, speakers, fall sensors, smoke alarm, door sensors), a network communicator, and alert communication devices (e.g., server computer, phone, dome lights, audible alarm). The device notifies medical professionals and caregivers and is intended for use in the healthcare facility.

Sterilization Methods

Method

Contacts

PhoneEmail
1-320-275-3382customerservice@cresthealthcar

Regulatory Flags

DUNS number
151772415
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
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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B48419022710STATION,CHECK IN,LIFELINE,9171C19022712024-12-12
B48419022720STATION,CALL CORD,LIFELINE,9171C19022722024-12-12
B48430000010CORRIDOR LIGHT,EEI30000012024-12-12
B48430000020AUDIO VISUAL PATIENT STATION,EEI30000022024-12-12
B48430000030VISUAL PATIENT STATION,EEI30000032024-12-12
B48430000060STATION,DUTY,EEI30000062024-12-12
B48430000070STATION,PUSH/PULL FOR HELP,NWP,EEI30000072024-12-12
B48430000080STATION,PUSH FOR HELP,RED,EEI30000082024-12-12

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