Catalog Number

20178

Brand Name

Scav Circuit - BelMed

Version/Model Number

20178

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 21, 2199

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

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

K033503

Product Code

CBN

Product Code Name

Apparatus, Gas-Scavenging

Public Device Record Key

3307b66a-efac-4868-a60b-9fbb583be8d8

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-