Catalog Number

392523

Brand Name

Insyte Autoguard BC Pro

Version/Model Number

392523

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

FOZ

Product Code Name

Catheter, intravascular, therapeutic, short-term less than 30 days

Public Device Record Key

f022d9b2-a105-4b5c-9c50-b79dd625ca0f

Public Version Date

September 10, 2021

Public Version Number

1

DI Record Publish Date

September 02, 2021

Package DI Number

30382903925231

Quantity per Package

50

Contains DI Package

00382903925230

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfpack