Catalog Number

-

Brand Name

JOHN BUNN

Version/Model Number

GF81370

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CAI

Product Code Name

Circuit, Breathing (W Connector, Adaptor, Y Piece)

Public Device Record Key

0b6385db-cfdf-4de1-b230-c01c30a02311

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Package DI Number

M368GF813702

Quantity per Package

40

Contains DI Package

M368GF813701

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box