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
06948538362563Water ChamberWT-C12022-08-29
06948538340165Siesta Contour Nasal MaskN5A+ (Small)2026-02-02
06948538340172Siesta Contour Nasal MaskN5A+ (Medium)2026-02-02
06948538340189Siesta Contour Nasal MaskN5A+ (Large)2026-02-02
06948538340196Siesta Contour Nasal MaskN5A+ (Extra Large)2026-02-02
06948538340202Siesta Contour Nasal MaskN5A+ (All Size Kit)2026-02-02
06948538340219Siesta Contour Nasal MaskN5A+ (All Size Kit)-Sample2026-02-02
06948538340226Siesta Contour Nasal MaskN5A+ (Small)-Sleep Lab2026-02-02
06948538340233Siesta Contour Nasal MaskN5A+ (Medium)-Sleep Lab2026-02-02
06948538340240Siesta Contour Nasal MaskN5A+ (Large)-Sleep Lab2026-02-02
06948538340257Siesta Contour Nasal MaskN5A+ (Extra Large)-Sleep Lab2026-02-02
06948538340264Siesta Contour Nasal MaskN5A+ (All Size Kit)-Sleep Lab2026-02-02
16948538340162Siesta Contour Nasal MaskN5A+ (Small)2026-02-02
16948538340179Siesta Contour Nasal MaskN5A+ (Medium)2026-02-02
16948538340186Siesta Contour Nasal MaskN5A+ (Large)2026-02-02
16948538340193Siesta Contour Nasal MaskN5A+ (Extra Large)2026-02-02
16948538340209Siesta Contour Nasal MaskN5A+ (All Size Kit)2026-02-02
16948538340216Siesta Contour Nasal MaskN5A+ (All Size Kit)-Sample2026-02-02
16948538340223Siesta Contour Nasal MaskN5A+ (Small)-Sleep Lab2026-02-02
16948538340230Siesta Contour Nasal MaskN5A+ (Medium)-Sleep Lab2026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344011858HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011865HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
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10197344011889HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011896HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011902HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011919HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011926HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011933HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011940HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011957HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011964HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
00848530109677CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
00848530109684CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
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00198843003699Infant Flow™Zoll Medical CorporationBZD2026-08-14
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