FDA.reportPublic FDA data

PAP Link

Primary DI
06948538369173
Brand
PAP Link
Company
BMC Medical Co., Ltd.
Model
PAP Link PC
Device description
PAP Link
Published
2025-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242935000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242935000Respiration Data Management Software (PAP Link PC)BMC Medical Co., Ltd.2025-01-15BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948538369173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948538369173069485383691736948538369173

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

Regulatory Flags#

DUNS number
526010310
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948538347683Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347690Alto Nasal Pillows InterfaceP6S (Small)2026-10-15
06948538347706Alto Nasal Pillows InterfaceP6S (Medium)2026-10-15
06948538347713Alto Nasal Pillows InterfaceP6S(Large)2026-10-15
06948538347720Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347737Alto Nasal Pillows InterfaceP6S(Small)2026-10-15
06948538347744Alto Nasal Pillows InterfaceP6S(Medium)2026-10-15
06948538347751Alto Nasal Pillows InterfaceP6S(Large)2026-10-15
06948538347768Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347775Alto Nasal Pillows InterfaceP6S(Small)2026-10-15
06948538347782Alto Nasal Pillows InterfaceP6S(Medium)2026-10-15
06948538347799Alto Nasal Pillows InterfaceP6S(Large)2026-10-15
06948538347805Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347812Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347829Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347836Alto Full Face MaskF6S (All Size Kit)2026-10-15
06948538347843Alto Full Face MaskF6S (Small)2026-10-15
06948538347850Alto Full Face MaskF6S (Medium)2026-10-15
06948538347867Alto Full Face MaskF6S(Large)2026-10-15
06948538347874Alto Full Face MaskF6S (All Size Kit)2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948538347683Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347690Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347706Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347713Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347720Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347737Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347744Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347751Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347768Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347775Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347782Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347799Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347805Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347812Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347829Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347836Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347843Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347850Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347867Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347874Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347881Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347898Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347904Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347911Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347928Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347935Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347942Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347959Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347966Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347973Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15