FDA.reportPublic FDA data

Tian Medical

Primary DI
20864915000302
Brand
Tian Medical
Company
Tian Medical, LLC
Model
Tx360EU
Device description
Tx360EUTM Nasal Applicator
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20864915000302PackageGS110In Commercial Distribution
00864915000339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086491500030220864915000302
00864915000339008649150003398649150003390864915000339

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
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
false
Expiration date on label
true
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
00864915000339Tian MedicalTx360EU2024-04-05
00864915000308Tian MedicalTx3602021-05-18

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
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
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