FDA.reportPublic FDA data

Nebulizer, Hand Held

Primary DI
00817081026436
Brand
Nebulizer, Hand Held
Company
A-M SYSTEMS, LLC
Model
Nebulizer, Hand Held - 166305
Catalog number
166305
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
OTC
false
Sterile
false
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
00817081026436PackageGS110In Commercial Distribution
00817081026429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817081026436008170810264368170810264360817081026436
00817081026429008170810264298170810264290817081026429

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.

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
false
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
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
00817081026405Nebulizer, Hand HeldA-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
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