FDA.reportPublic FDA data

n/a

Primary DI
00607411008245
Brand
n/a
Company
SALTER LABS
Model
SO-435
Catalog number
SO-435
Device description
Adult Mask Elastic strap style, Under the chin fit, Vinyl
Published
2016-11-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CATCANNULA, NASAL, OXYGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411008242PackageGS1100Not in Commercial Distribution
00607411008245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741100824210607411008242
00607411008245006074110082456074110082450607411008245

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00N/A
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411919008Salter Labs® Adult Comfort Face Tent131032026-06-09
00607411919053Salter Labs® Oxygen Mask131242026-06-09
00607411919060Salter Labs® Oxygen Mask131252026-06-09
00607411919084MedTronic Cannula133012026-06-09
00607411919107Salter Labs® Nasal Cannula133072026-06-09
00607411919138Salter Labs® Nasal Cannula133102026-06-09
00607411919206MedTronic ETCo2 Cannula133402026-06-09
00607411919220Salter Labs® Oxygen Tubing134002026-06-09
00607411919237Salter Labs® Oxygen Tubing134042026-06-09
00607411919244Salter Labs® Oxygen Tubing134072026-06-09
00607411919251Salter Labs® Oxygen Tubing (MedTronic)134082026-06-09
00607411919299MedTronic NebuTech135002026-06-09
00607411919329Salter Labs® NebuTech®135062026-06-09
00607411919350Salter Labs® Full Kit Nebulizer139512026-06-09
00607411000737N/A8900-148900-142016-09-24
00607411006814N/ASO-1343SO-13432016-09-24
00607411009297N/ASO-1666-0SO-1666-02016-09-24
00607411102738N/A7914-147914-142016-12-22
00607411300059N/ASO-388-0SO-388-02016-09-24
00607411700002N/A7100-07100-02016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919084MedTronic CannulaSALTER LABSCAT2026-06-09
00607411919107Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-09
00607411919138Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-09
10197344155125MEDLINEMEDLINE INDUSTRIES, INC.CAT2026-01-29
10197344158478HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-10-17
10197344158409HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158416HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158423HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158430HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158447HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158454HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158461HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161164MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161171MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161188MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161195MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161201MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161218MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161225MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161232MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344155064MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21
10197344155101MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21
10197344158522MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21
10197344009664HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344009985HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344010004HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344011254HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344011261HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344042210HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344042227HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13