FDA.reportPublic FDA data

N/A

Primary DI
00607411005688
Brand
N/A
Company
SALTER LABS
Model
M016477-0
Catalog number
M016477-0
Device description
Nasal Cannula (Adult) TLCannulaTM with 7’ (2.1 m) supply tube.
Published
2016-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
10607411005685PackageGS125In Commercial Distribution
00607411005688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741100568510607411005685
00607411005688006074110056886074110056880607411005688

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, basic"A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as ""nasal prongs"". 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
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
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
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00818834029063CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029087CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029100CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029124CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029148CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029162CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029186CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00607411917332Salter LabsSALTER LABSCAT2026-10-07
00607411917363Salter LabsSALTER LABSCAT2026-10-07
00607411917394Salter LabsSALTER LABSCAT2026-10-07
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