Catalog Number

-

Brand Name

CAP (11 MM)

Version/Model Number

8401644

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"

-

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

BZO

Product Code Name

Set, Tubing And Support, Ventilator (W Harness)

Public Device Record Key

afc8fa39-c8ef-4479-a44f-ad7e3d4ec936

Public Version Date

October 21, 2020

Public Version Number

5

DI Record Publish Date

October 24, 2015

Package DI Number

04048675176527

Quantity per Package

5

Contains DI Package

04048675176237

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-