Catalog Number

-

Brand Name

Cadwell Disposable Patient Pak Refill

Version/Model Number

302120-000

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

K933803,K933803,K933803

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

6ca7dc9f-fce5-403d-9059-06b5b6c22a64

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

September 05, 2016

Package DI Number

10840067101343

Quantity per Package

30

Contains DI Package

00840067101346

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case