FDA.reportPublic FDA data

DirectView

Primary DI
00606959028630
Brand
DirectView
Company
Respironics, Inc.
Model
DirectView PC Software Application, Web - 2
Catalog number
1063558
Device description
DirectView Software Version 2.4
Published
2016-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVENTILATOR, CONTINUOUS, FACILITY USE
MNSVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
MNTVENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
NHJDEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2
MNTSv70 VentilatorAnesthesiology2
NHJDevice, Positive Pressure Breathing, IntermittentAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606959028630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606959028630006069590286306069590286300606959028630

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment clinical data interfacing softwareAn application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)744-2500respironics.service@philips.com

Regulatory Flags#

DUNS number
080728314
Device count
1
Lot or batch
true

Other Devices From This Company#

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00606959424944DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell,AUX1131H15C2017-02-10
00606959424951DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Cell, AUAUX1131S15C2017-02-10
00606959424968DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/CeAUX1131T15C2017-02-10
00606959424975DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi,AUX1131H15W2017-02-10
00606959424982DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/WiFi, AUAUX1131S15W2017-02-10
00606959424999DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/WAUX1131T15W2017-02-10
00606959425378DreamStation01CNX1130T172019-12-29
00606959425385DreamStation01CNX1131H172019-12-29
00606959425392DreamStation01CNX1131S172019-12-29
00606959425408DreamStation01CNX1131T172019-11-20
00606959425484DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/CellCAX900T12C2017-02-01
00606959425491DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/WiFiCAX900T12W2017-02-01
00606959425538DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/Cell, CACAX1130H12C2017-02-10
00606959425545DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Cell, CACAX1130S12C2017-02-10
00606959425552DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humid w/H Tube w/CellCAX1130T12C2017-02-10
00606959425569DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/WiFi, CACAX1130H12W2017-02-10
00606959425576DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/WiFi, CACAX1130S12W2017-02-10

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