Catalog Number

70907-05

Brand Name

Precision Xceed Pro

Version/Model Number

70907-05

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080960

Product Code

JIN

Product Code Name

NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)

Public Device Record Key

adb5f9d2-e1f6-4e2a-821c-f8456d4a53d7

Public Version Date

December 11, 2019

Public Version Number

5

DI Record Publish Date

August 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-