FDA.reportPublic FDA data

Nebulizer, Hand Held

Primary DI
00817081026405
Brand
Nebulizer, Hand Held
Company
A-M SYSTEMS, LLC
Model
Nebulizer, Hand Held - 166300
Catalog number
166300
Device description
Nebulizer, Hand Held
Published
2020-04-10
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
EPNPump, Nebulizer, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPNPump, Nebulizer, ManualEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817081026412PackageGS150In Commercial Distribution
00817081026405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817081026412008170810264128170810264120817081026412
00817081026405008170810264058170810264050817081026405

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system delivery set, single-useA collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.

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
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
00817081028423PFT Kit B, VBMax35 w/ Blue Foam Nose clipPFT Kit B, VBMax35 - 1801151801152025-04-03
00817081028416VBMax28, PF Testing FilterVBMax28, PF Testing Filter - 1569041569042025-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976262370240Shenzhen Bona PharmaShenzhen Bona Pharma Technology Co., Ltd.EPN2026-03-05
00864915000339Tian MedicalTian Medical, LLCEPN2024-04-05
20864915000302Tian MedicalTian Medical, LLCEPN2024-04-05
00864915000308Tian MedicalTian Medical, LLCEPN2021-05-18
00817081026382Nebulizer, Hand Held, Tee AdapterA-M SYSTEMS, LLCEPN2020-04-10
00817081026429Nebulizer, Hand HeldA-M SYSTEMS, LLCEPN2020-04-10
00817081026399Nebulizer, Hand Held, Tee AdapterA-M SYSTEMS, LLCEPN2020-04-10
00817081026412Nebulizer, Hand HeldA-M SYSTEMS, LLCEPN2020-04-10
00817081026436Nebulizer, Hand HeldA-M SYSTEMS, LLCEPN2020-04-10
00817081026443Innospire MiniA-M SYSTEMS, LLCEPN2020-04-10
00817081026450Option Home w/ Side Stream, Disposable NebulizerA-M SYSTEMS, LLCEPN2020-04-10
00817081026320Nebulizer, Side Stream, DisposableA-M SYSTEMS, LLCEPN2020-04-09
00817081026368Nebulizer, Hand Held, Tee AdapterA-M SYSTEMS, LLCEPN2020-04-09
00817081026337Nebulizer, Side Stream, DisposableA-M SYSTEMS, LLCEPN2020-04-09
00817081026344Nebulizer, Side Stream, Re-UsableA-M SYSTEMS, LLCEPN2020-04-09
00817081026375Nebulizer, Hand Held, Tee AdapterA-M SYSTEMS, LLCEPN2020-04-09
00817081026306"Nebulizer, Hand Held, Tee Adapter, 84"" Tube"A-M SYSTEMS, LLCEPN2020-04-06
00817081026313Nebulizer, Hand Held, Tee Adapter, 84" TubeA-M SYSTEMS, LLCEPN2020-04-06