Catalog Number

H93816004

Brand Name

TWOFER

Version/Model Number

H93816004

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"

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

K832347,K832347

Product Code

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

83224ccf-3283-47be-927e-aecd8535c5b3

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

50085412478390

Quantity per Package

100

Contains DI Package

00085412478395

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE