Catalog Number

TH01300

Brand Name

Tidal High-Flow Non-coring Needle

Version/Model Number

Tidal-HF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K151341,K151341

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

922fa071-ddc5-4c68-aaac-68449719b39f

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

October 06, 2015

Package DI Number

M991TH013002

Quantity per Package

10

Contains DI Package

M991TH013001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box