FDA.report

REMOTE ALARM

Primary DI
00619498279043
Brand
REMOTE ALARM
Company
RESMED LIMITED
Model
27904
Catalog number
27904
Device description
REMOTE ALARM II CABLE 2M
Published
2016-09-30
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

Contact Domains

Product Codes

CodeName
MNTVentilator, Continuous, Minimal Ventilatory Support,Facility Use

Product Code Classifications

CodeDeviceSpecialtyClass
MNTSv70 VentilatorAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00619498279043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498279043006194982790436194982790430619498279043

GMDN Terms

TermDefinition
Airway pressure alarmA battery-powered warning device that monitors a patient's upper airway pressure during assisted mechanical ventilation; it typically being connected to the breathing circuit. In the event of either the pressure not rising above a minimum threshold within a maximum time span or exceeding a pre-set maximum level, the device will signal a warning.

Sterilization Methods

Method

Contacts

PhoneEmail
800-424-0737reception@resmed.com

Regulatory Flags

DUNS number
751149311
Device count
1
DM exempt
false
Premarket exempt
false
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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