Catalog Number

VA00219

Brand Name

FEATHERLITE AQUA

Version/Model Number

TDW-NB

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"

-

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

-

Product Code

HFM

Product Code Name

Monitor, Uterine Contraction, External (For Use In Clinic)

Public Device Record Key

59231ef1-515c-4c0d-b5d7-055aaf2c3e7e

Public Version Date

June 05, 2020

Public Version Number

3

DI Record Publish Date

August 18, 2016

Package DI Number

VA002191

Quantity per Package

25

Contains DI Package

B249VA002191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX