Catalog Number

-

Brand Name

Set, I.V. Fluid Transfer

Version/Model Number

BG-006-08

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

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

K955896,K955896

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

eac3e88e-f706-455b-8c67-1cd9e14a46a8

Public Version Date

January 14, 2021

Public Version Number

1

DI Record Publish Date

January 06, 2021

Package DI Number

10816513023422

Quantity per Package

50

Contains DI Package

00816513023425

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX