Catalog Number

141NX7P

Brand Name

SWAN-GANZ HI-SHORE

Version/Model Number

141NX7P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K193466,K193466

Product Code

DQE

Product Code Name

Catheter, Oximeter, Fiber-Optic

Public Device Record Key

47101723-0f86-451f-9002-074db4d1e1cb

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

September 18, 2020

Package DI Number

50690103198565

Quantity per Package

5

Contains DI Package

00690103198560

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SHIPPER