FDA.report

Trilogy O2 Ventilator,Japan-RECERT

Primary DI
00606959033948
Brand
Trilogy O2 Ventilator,Japan-RECERT
Company
Respironics, Inc.
Model
00
Catalog number
U1040004
Device description
Trilogy O2 Ventilator, Recertified, Japan
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DQAOximeter

Product Code Classifications

CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions

SubmissionSupplement
K093905000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K093905000TRILOGY 202 VENTILATORRespironics, Inc.2010-05-12CBK

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00606959033948PrimaryGS10

GMDN Terms

TermDefinition
Portable electric ventilatorA portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(724)744-2500respironics.service@philips.com

Regulatory Flags

DUNS number
080728314
Device count
1
DM exempt
false
Premarket exempt
false
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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