Catalog Number

80035

Brand Name

SPRINT

Version/Model Number

Patient Kit, Endura

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)

Yes

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

NIH

Product Code Name

Disinfectant, Subsystem, Water Purification

Public Device Record Key

bb66e58a-5072-47b4-bbc2-f647a627635c

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

September 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-