AccessGUDID - DEVICE: Tian Medical (00864915000308)

GUDID

Device Identifier (DI) Information

Brand Name: Tian Medical
Version or Model: Tx360
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tian Medical, LLC

Primary DI Number: 00864915000308
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070075971 *Terms of Use

Device Description: Tx360™ Nasal Applicator

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45332	Nasopharyngeal medicine administration kit	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EPN	Pump, Nebulizer, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: da9d3ea5-8606-4008-9e3d-a07c6b95e7d5
Public Version Date: June 09, 2021
Public Version Number: 2
DI Record Publish Date: May 18, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00864915000315	10	00864915000308		In Commercial Distribution	Inner Pack

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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