NA - Non-invasive Blood Pressure Hose, 3 meter. Female - ZOE MEDICAL INCORPORATED

Duns Number:848429929

Device Description: Non-invasive Blood Pressure Hose, 3 meter. Female HP Connectors.

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More Product Details

Catalog Number

180-1014

Brand Name

NA

Version/Model Number

NIBP Hose, 3 meter

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

Yes

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

K130740

Product Code Details

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

55890414-b6d3-46c1-983e-a678ddb2f3f6

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZOE MEDICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 45