Catalog Number

BCC1

Brand Name

J-VAC

Version/Model Number

BCC1

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

-

Product Code

GBX

Product Code Name

CATHETER, IRRIGATION

Public Device Record Key

2e550798-afee-448c-9da6-091c0a813def

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2015

Package DI Number

20705031023311

Quantity per Package

20

Contains DI Package

10705031023314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE