Catalog Number

15063-000-0001

Brand Name

PCA Lockbox 250mL

Version/Model Number

15063-000-0001

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

K141389,K141389,K141389

Product Code

MRZ

Product Code Name

Accessories, Pump, Infusion

Public Device Record Key

817a9c00-9c4d-44e7-867b-9c45b5f00503

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

27290109150073

Quantity per Package

3

Contains DI Package

17290109150076

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cardboard box