FDA.reportPublic FDA data

Nasal Cannula, Non-Flare, Non-Crush Resistant

Primary DI
00817081023244
Brand
Nasal Cannula, Non-Flare, Non-Crush Resistant
Company
A-M SYSTEMS, LLC
Model
Nasal Cannula - 125000
Catalog number
125000
Device description
Nasal Cannula, Non-Flare, Non-Crush Resistant
Published
2019-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00817081023244PackageGS150In Commercial Distribution
00817081023237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817081023244008170810232448170810232440817081023244
00817081023237008170810232378170810232370817081023237

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory oxygen therapy systemAn assembly of devices designed to be interconnected to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at different concentrations (e.g., via a gas mixer), duration of use, and flows. It will connect to an oxygen source and will typically include a flowmeter or flow controlling device, masks, tubing, valves, and/or nasal cannulae. It can also include, e.g., a high pressure gas reduction valve(s) and a pneumatically-powered suction device with collection bottle.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3606838300sales@a-msystems.com

Regulatory Flags#

DUNS number
020275145
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817081028553VBMax28s, PF Testing Filter Labeled DR BurtonVBMax28s, DR Burton - VBMax28s1369042025-08-07
00817081028577VBMax28e, PF Testing Filter Labeled DR BurtonVBMax28e, DR Burton - VBMax28e1469042025-08-07
00817081028515VBMAX34, DISPOSABLE PF TESTING FILTERVBMAX34 - 1564002025-06-25
00817081028539PFT KIT J, VBMax34S w/ Blue Rubber Nose clipPFT KIT J, VBMax34S - 1871741871742025-06-25
00817081028492VBMax34, PF Testing Filter Labeled DR BurtonVBMax34, PF Testing Filter - 1564041564042025-06-03
00817081028478PFT Kit B, VBMax35PFT Kit B, VBMax35 - 1801141801142025-05-12
00817081028454PFT Kit J, VBMax31SPFT Kit J, VBMax31S - 1871411871412025-05-02
00817081028416VBMax28, PF Testing FilterVBMax28, PF Testing Filter - 1569041569042025-04-03
00817081028430PFT Kit B, VBMax35 w/ Blue Foam Nose clipPFT Kit B, VBMax35 - 1801151801152025-04-03
00817081028393PFT Kit I, VBMax36S w/ Foam Nose Clip and 164900PFT Kit I, VBMax36S - 1872661872662025-04-02
00817081028379PFT Kit B, VBMax48PFT Kit B, VBMax48 - 1881021881022025-03-24
00817081028355Pulmonary Function Test Kit EPulmonary Function Test Kit E - 1891241891242025-02-28
00817081028270PFT Kit E, VBMax36E PFT Kit E, VBMax36E - 1891391891392025-02-25
00817081028294Disposable White PFT Nose Clip with Rubber Pads, Labeled D R BurtonDisposable White PFT Nose Clip with Rubber Pads - 1660042025-02-25
00817081028317Disposable Blue PFT Nose Clip with Rubber PadsDisposable Blue PFT Nose Clip - 1667041667042025-02-25
00817081028331Disposable Blue PFT Nose Clip with Foam PadsDisposable Blue PFT Nose Clip with Foam Pads - 1661669042025-02-25
00817081028232Mouthpiece, Disposable, White, Thermoplastic, Bite Block StyleDisposable Mouthpiece, Bite Block Style - 1649041649042025-02-21
00817081028256Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue DepressingBreathebite Mouthpiece - 1649541649542025-02-21
00817081028218PFT Nose Clip with Foam PadsPFT Nose Clip with Foam Pads1665042025-02-20
00817081028195Pulmonary Function Test Kit EPFT Kit E - 1891251891252025-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344155122MEDLINEMEDLINE INDUSTRIES, INC.CAT2026-01-29
20885632467384HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
20885632467391HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
20885632467445HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
20885632467452HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
15694311111894Nox Nasal Pressure Cannula with FilterNox Medical ehf.CAT2026-01-28
00850077887017AERIS Airway - MSA Luer KitAirway Innovations, Inc.CAT2026-01-08
00850077887048AERIS Airway - Male Luer KitAirway Innovations, Inc.CAT2026-01-08
00850077887079AERIS Airway - Female Luer KitAirway Innovations, Inc.CAT2026-01-08
20889483223014Montgomery DMESUNMED, LLCCAT2025-12-30
20197344162694CARINGMEDLINE INDUSTRIES, INC.CAT2025-11-27
20197344158406HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158413HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158420HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158437HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158444HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158451HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
05030267165322I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULTIntersurgical IncorporatedCAT2025-09-23
05030267165346I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, MEDIUM ADULTIntersurgical IncorporatedCAT2025-09-23
05030267165360HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULTIntersurgical IncorporatedCAT2025-09-23
20197344158468HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161161MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161178MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161185MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161192MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161208MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161215MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161222MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161239MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344155061MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21