FDA.reportPublic FDA data

DreamMapper Web (EMEA)

Primary DI
00606959054851
Brand
DreamMapper Web (EMEA)
Company
Respironics, Inc.
Model
2.18
Catalog number
1128262
Device description
DreamMapper Web EU Instance, Version 2.18
Published
2020-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
MNSVentilator, continuous, non-life-supporting
MNTVentilator, continuous, minimal ventilatory support, facility use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2
MNTSv70 VentilatorAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606959054851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606959054851006069590548516069590548510606959054851

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080728314
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606959055735Sleepware G3Sleepware G32026-01-22
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

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Primary DI, Brand, Company table
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00198843003422Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003545Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003552Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003569Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003576Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003583Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003590Infant Flow™Zoll Medical CorporationBZD2026-06-24
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00814747024942MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024959MiniMe 2 Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024966MiniMe 2 Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024973Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024980Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024997Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747025000Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109042CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109059CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109066CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00814747024850Novaplus Pediatric Nasal Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-06-03
00814747024867Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-03
00814747024874Novaplus Pediatric Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-06-03
00814747024881Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-03