Catalog Number

132F5

Brand Name

SWAN-GANZ TRUE SIZE

Version/Model Number

132F5

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)

Yes

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

K160084

Product Code

DQE

Product Code Name

CATHETER, OXIMETER, FIBEROPTIC

Public Device Record Key

754e5524-c8fe-494f-9aca-6a411c226baf

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

-