Catalog Number

-

Brand Name

Philips, Datascope, Spacelabs y Mindray T5 NIBP Hose: Adult NIBP Hose

Version/Model Number

AS-15-150

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173197

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

31046c6d-14ad-4cfb-ae6d-37069dbea918

Public Version Date

July 30, 2021

Public Version Number

1

DI Record Publish Date

July 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-