Catalog Number

SP-BD-100

Brand Name

PREFERRED MEDICAL PRODUCTS, LLC

Version/Model Number

SP-BD-100

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K890272,K890272

Product Code

KPE

Product Code Name

Container, I.V.

Public Device Record Key

49b2b7e9-62d2-4029-9686-d59e3b33f81d

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

August 30, 2016

Package DI Number

20680211002570

Quantity per Package

50

Contains DI Package

00680211002576

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX