Tian Medical

GUDID 00864915000308

Tx360™ Nasal Applicator

Tian Medical, LLC

Nasopharyngeal medicine administration kit
Primary Device ID00864915000308
NIH Device Record Keyda9d3ea5-8606-4008-9e3d-a07c6b95e7d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTian Medical
Version Model NumberTx360
Company DUNS070075971
Company NameTian Medical, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100864915000308 [Primary]
GS100864915000315 [Package]
Package: Inner Pack [10 Units]
In Commercial Distribution

FDA Product Code

EPNPump, Nebulizer, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-26
Device Publish Date2021-05-18

On-Brand Devices [Tian Medical]

00864915000308Tx360™ Nasal Applicator
20864915000302Tx360EUTM Nasal Applicator

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