FDA.reportPublic FDA data

Omnilab Direct

Primary DI
00606959044296
Brand
Omnilab Direct
Company
Respironics, Inc.
Model
2.12
Catalog number
1113127
Device description
Software, OmniLab Direct, Web
Published
2017-04-28
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNSVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606959044296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606959044296006069590442966069590442960606959044296

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator IMV controllerAn unit that, added to a ventilator otherwise incapable of providing intermittent mandatory ventilation (IMV) or synchronized intermittent mandatory ventilation (SIMV) functions, permits the ventilator to provide this kind of breathing mode to the patient during his/her attempts at spontaneous breathing.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606959055735Sleepware G3 Sleepware G3 2026-01-22
00606959060586Care OrchestratorCare Orchestrator2026-01-22
00606959424852DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H tube w/Cell,AUX900T15C2017-02-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07321820070060Vivo 1/2, Vivo 3Breas Medical ABMNS2025-05-20
07321820072033Vivo 1/2, Vivo 3Breas Medical ABMNS2025-05-20
07321820069903Vivo 1/2, Vivo 3Breas Medical ABMNS2025-05-19
07321820070008Vivo 1/2, Vivo 3Breas Medical ABMNS2025-05-19
07321822270000Vivo 1/2Breas Medical ABMNS2025-05-19
07321822280009Vivo 1/2Breas Medical ABMNS2025-05-19
00840193400276AirViewRESMED CORP.MNS2024-10-02
10850001175026ReddyPortSMD Manufacturing LLCMNS2024-01-16
10850001175064ReddyPortSMD Manufacturing LLCMNS2024-01-16
10850001175071ReddyPortSMD Manufacturing LLCMNS2024-01-16
00619498282852AIRCURVERESMED PTY LTDMNS2022-06-10
00840193400108AirViewRESMED CORP.MNS2021-11-30
10850001175002ReddyPortSMD Manufacturing LLCMNS2020-10-28
00606959428607DreamStation ST30Respironics, Inc.MNS2020-10-16
00606959048720A Series, Sys One, Heater HumRespironics, Inc.MNS2020-10-16
00606959048744BiPAP A30Respironics, Inc.MNS2020-10-16
00606959048751BiPAP A30Respironics, Inc.MNS2020-10-16
00606959048768BiPAP A30Respironics, Inc.MNS2020-10-16
00606959049062DreamMapper Mobile App Android (EMEA)Respironics, Inc.MNS2020-10-16
00606959049079DreamMapper Mobile App Android (APAC)Respironics, Inc.MNS2020-10-16
00606959049413BiPAP ST C Series Argentina, 30Respironics, Inc.MNS2020-10-16
00606959050938DreamStation ST30Respironics, Inc.MNS2020-10-16
00606959051362DreamMapper iOS China InstanceRespironics, Inc.MNS2020-10-16
00606959054691BiPAP V30 AutoRespironics, Inc.MNS2020-10-15
00606959061958A Series HumidifierRespironics, Inc.MNS2020-10-15
00606959424524DreamStationRespironics, Inc.MNS2020-09-23
00606959424869DreamStationRespironics, Inc.MNS2020-09-23
00606959424883DreamStationRespironics, Inc.MNS2020-09-23
00606959040601DreamStationRespironics, Inc.MNS2020-09-23
00606959040625DreamStationRespironics, Inc.MNS2020-09-23