FDA.reportPublic FDA data

N/A

Primary DI
00607411945489
Brand
N/A
Company
SALTER LABS
Model
SYL201
Catalog number
SYL201
Device description
Sylent Nasal Mask - SM
Published
2017-09-01
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)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050171000IT NASAL MASKInnomed Technologies2005-05-04BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411945486PackageGS130In Commercial Distribution
00607411945489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741194548610607411945486
00607411945489006074119454896074119454890607411945489

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, reusableA flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)421-0024customercare@salterlabs.com

Regulatory Flags#

DUNS number
022721133
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411890178N/A891289122016-09-24
00607411890185N/A891389132016-09-24
00607411890246N/A892389232016-09-24
00607411000881N/A5006-15006-12016-09-24
00607411917332Salter LabsOTC-101-7 (QTY 5)OTC-101-7 (QTY 5)2026-10-07
00607411917363Salter LabsOTC-102-4 (QTY 5)OTC-102-4 (QTY 5)2026-10-07
00607411917394Salter LabsOTC-102-7 (QTY 5)OTC-102-7 (QTY 5)2026-10-07
00607411000966AirLife7001-07001-02016-11-30
00607411001130AirLife1220-01220-02016-11-30
00607411001215AirLife1225-01225-02016-11-30
00607411888922N/AM5120-0M5120-02016-09-24
00607411917615n/aOTC-203-25 (QTY1)OTC-203-25 (QTY1)2016-11-30
00607411917646n/aOTC-203-50 (QTY1)OTC-203-50 (QTY1)2016-11-30
00607411918346Salter AIRE EliteSO-1774BESO-1774BE2016-09-24
00607411400711N/ASO-431SO-4312016-09-24
10607411920117N/AM123138-0M123138-02016-09-24
00607411000409N/ASO-1394SO-13942016-09-24
00607411000461N/ASO-1392-0SO-1392-02016-09-24
00607411000478N/ASO-1393SO-13932016-09-24
00607411005756N/ASO-1608-0SO-1608-02016-09-24

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