FDA.reportPublic FDA data

ResScan

Primary DI
08401934313396
Brand
ResScan
Company
RESMED CORP.
Model
31339
Device description
ResScan V7.0.2
Published
2023-02-24
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
BZDVentilator, Non-Continuous (Respirator)
CBKVentilator, Continuous, Facility Use
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
CBKVentilator, Continuous, Facility UseAnesthesiology2
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2
MNTSv70 VentilatorAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08401934313396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08401934313396084019343133968401934313396

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator application softwareAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a ventilator. A basic set of applications programs and routines are included with the ventilator and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.424.0737reception@resmed.com

Regulatory Flags#

DUNS number
080243150
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840193400276AirView22240222402024-10-02
00840193400115myAir22245222452021-07-28
00840193400122myAir22246222462021-07-28
00840193400191ResScan313372023-03-07
08401934313389ResScan313382023-02-24
00840193400108AirView22240222402021-11-30
00840193400023RMDpulse222542021-04-13
00840193400030RMDpulse222532021-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00814747024898Novaplus Pediatric Nasal Non Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-06-03
00814747024904Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-03
00814747024911Novaplus Pediatric Nasal Non Vented Mask, MediumSLEEPNET, CORP.BZD2026-06-03
00814747024928Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-03
00848530109097CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109264CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109271CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109288CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
04719893348873WellellWellell Inc.BZD2026-06-01
09420012464668Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-19
09420012423573Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012425034Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012425041Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448446Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
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09420012456434Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464644Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464682Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18