Catalog Number

W091-012

Brand Name

WASP-FLO™ Hopper Module

Version/Model Number

W091-012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

JQP

Product Code Name

Calculator/Data Processing Module, For Clinical Use

Public Device Record Key

0f60aa9f-a874-40f7-a899-3163fcb68c39

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

April 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-