Catalog Number

S9FC146F7

Brand Name

SWAN-GANZ

Version/Model Number

S9FC146F7

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"

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

K160084

Product Code

DQE

Product Code Name

CATHETER, OXIMETER, FIBEROPTIC

Public Device Record Key

fd7f57fa-c9eb-4442-91d7-897d14982303

Public Version Date

March 10, 2021

Public Version Number

5

DI Record Publish Date

September 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-