Catalog Number

-

Brand Name

Pediatric Disposable Cuff, Double Hose, BP48 Connector, Box of 5

Version/Model Number

10127

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

fb58f15a-1d99-4e8b-9281-886768e153d5

Public Version Date

November 23, 2020

Public Version Number

1

DI Record Publish Date

November 13, 2020

Package DI Number

B817101271

Quantity per Package

5

Contains DI Package

B817101270

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-