Catalog Number

A/NTX2-POUCH

Brand Name

NA

Version/Model Number

A/NTX2-POUCH

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

-

Product Code

DRT

Product Code Name

MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

Public Device Record Key

2c86b7d1-cf70-4254-82e3-6760a6a3a75b

Public Version Date

May 07, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-