FDA.reportPublic FDA data

Nasal Cannula Disposable 7Ft

Primary DI
00817081023251
Brand
Nasal Cannula Disposable 7Ft
Company
A-M SYSTEMS, LLC
Model
Nasal Cannula Disposable 7Ft - 125200
Catalog number
125200
Device description
Nasal Cannula, Non-Flare, Non-Crush Resistant 7Ft
Published
2019-12-17
Public version status
New
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
00817081023268PackageGS150In Commercial Distribution
00817081023251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817081023268008170810232688170810232680817081023268
00817081023251008170810232518170810232510817081023251

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.

Contacts#

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

Regulatory Flags#

DUNS number
020275145
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817081028683PFT KIT F, VBMax 35e Filter KitPFT KIT F, VBMax 35e - 1891751891752026-07-17
00817081028669PFT Kit J, 31s VBMax Filter with Blue Foam Nose ClipPFT Kit J, 31s VBMax - 1871921971922026-06-23
00817081028621Pulmonary Function Test Kit B, 36 MM O.D.PFT KIT B - 1841141841142026-04-24
00817081028607PFT Kit B, Disposable, 34 MMPFT Kit B, Disposable, 34 MM - 1831021831022025-11-06
00817081028584VBMax30E, Disposable PF Testing FilterVBMax30E - 1463091463092025-10-20
00817081028546VBMax28s, PF Testing Filter Labeled DR BurtonVBMax28s, DR Burton - VBMax28s1369042025-08-07
00817081028560VBMax28e, PF Testing Filter Labeled DR BurtonVBMax28e, DR Burton - VBMax28e1469042025-08-07
00817081028553VBMax28s, PF Testing Filter Labeled DR BurtonVBMax28s, DR Burton - VBMax28s1369042025-08-07
00817081028577VBMax28e, PF Testing Filter Labeled DR BurtonVBMax28e, DR Burton - VBMax28e1469042025-08-07
00817081028508VBMAX34, DISPOSABLE PF TESTING FILTERVBMAX34 - 1564002025-06-25
00817081028522PFT KIT J, VBMax34S w/ Blue Rubber Nose clipPFT KIT J, VBMax34S - 1871741871742025-06-25
00817081028515VBMAX34, DISPOSABLE PF TESTING FILTERVBMAX34 - 1564002025-06-25
00817081028539PFT KIT J, VBMax34S w/ Blue Rubber Nose clipPFT KIT J, VBMax34S - 1871741871742025-06-25
00817081028485VBMax34, PF Testing Filter Labeled DR BurtonVBMax34, PF Testing Filter - 1564041564042025-06-03
00817081028492VBMax34, PF Testing Filter Labeled DR BurtonVBMax34, PF Testing Filter - 1564041564042025-06-03
00817081028461PFT Kit B, VBMax35PFT Kit B, VBMax35 - 1801141801142025-05-12
00817081028478PFT Kit B, VBMax35PFT Kit B, VBMax35 - 1801141801142025-05-12
00817081028447PFT Kit J, VBMax31SPFT Kit J, VBMax31S - 1871411871412025-05-02
00817081028454PFT Kit J, VBMax31SPFT Kit J, VBMax31S - 1871411871412025-05-02
00817081028409VBMax28, PF Testing FilterVBMax28, PF Testing Filter - 1569041569042025-04-03

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