FDA.reportPublic FDA data

Tian Medical

Primary DI
00864915000308
Brand
Tian Medical
Company
Tian Medical, LLC
Model
Tx360
Device description
Tx360™ Nasal Applicator
Published
2021-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
00864915000315PackageGS110In Commercial Distribution
00864915000308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864915000315008649150003158649150003150864915000315
00864915000308008649150003088649150003080864915000308

GMDN Terms#

Term, Definition table
TermDefinition
Nasopharyngeal medicine administration kitA collection of devices intended to be used to deliver an accurate dosage of medication, typically a local anaesthetic for an ear/nose/throat (ENT) procedure, into the nasal cavity and pharyngeal areas. It will typically include a medicine dispenser (i.e., a dedicated atomizing nozzle), a pump that allows delivery of a discrete volume of medication, and the medication in an appropriate container. This is a reusable device; the atomizer, however, is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070075971
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864915000339Tian MedicalTx360EU2024-04-05
20864915000302Tian MedicalTx360EU2024-04-05

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
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
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