Catalog Number

-

Brand Name

Neonate #5 Disposable Cuff Slip Single Hose Connector Box of 10

Version/Model Number

F1785SC05100

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

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

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

63726969-6f8c-49c1-bb82-b9c2d4ab0f45

Public Version Date

November 23, 2020

Public Version Number

1

DI Record Publish Date

November 13, 2020

Package DI Number

B817F1785SC051001

Quantity per Package

10

Contains DI Package

B817F1785SC051000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-