FDA.reportPublic FDA data

ResScan

Primary DI
08401934313389
Brand
ResScan
Company
RESMED CORP.
Model
31338
Device description
ResScan v7.0.1
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
08401934313389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08401934313389084019343133898401934313389

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
08401934313396ResScan313392023-02-24
00840193400108AirView22240222402021-11-30
00840193400023RMDpulse222542021-04-13
00840193400030RMDpulse222532021-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850085243003KricketSleepres, LLCBZD2026-10-13
00850085243010KricketSleepres, LLCBZD2026-10-13
00850085243027KricketSleepres, LLCBZD2026-10-13
00850085243034KricketSleepres, LLCBZD2026-10-13
00850085243041KricketSleepres, LLCBZD2026-10-13
00860008554369KricketSleepres, LLCBZD2026-10-13
00860008554376KricketSleepres, LLCBZD2026-10-13
00860008554383KricketSleepres, LLCBZD2026-10-13
00860008554390KricketSleepres, LLCBZD2026-10-13
00850088881196ZhangxinqiShenzhen Sany Pioneer Technology Co.,LtdBZD2026-10-08
00819989012399S10 Heated CPAP TubeEXCELERON MEDICAL, INC.BZD2026-10-05
00198843006454LTVZoll Medical CorporationCBK2026-09-18
00198843006492LTVZoll Medical CorporationCBK2026-09-18
00198843006515LTVZoll Medical CorporationCBK2026-09-18
00198843006539LTVZoll Medical CorporationCBK2026-09-18
00198843007352LTVZoll Medical CorporationCBK2026-09-18
10889483586358Vital Signs™AIRLIFEBZD2025-02-18
00848530081638CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530085230CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090661CPAP MaskSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090678CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090685CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090692CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090708CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090715CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090722CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090739CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090746CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097103CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097110CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29