Catalog Number

-

Brand Name

TandemLife LifeSPARC

Version/Model Number

5840-2417

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

-

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Public Device Record Key

2c265c1b-6eb3-434c-b2b2-e7475b6449af

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

June 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-