Catalog Number

PCIIVRE5TE

Brand Name

Patient Controlled Intravenous Analgesia Device (PCI)

Version/Model Number

PCI Tamper Evident

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K972158,K972158,K972158

Product Code

MEB

Product Code Name

Pump, Infusion, Elastomeric

Public Device Record Key

eb84ad57-5a63-4882-9c61-c3f446087565

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

May 18, 2017

Package DI Number

09350902000303

Quantity per Package

60

Contains DI Package

09350902000280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping carton