Catalog Number

-

Brand Name

XTRA

Version/Model Number

SEQUESTRATION SET X

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

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

K101586,K101586,K101586

Product Code

CAC

Product Code Name

APPARATUS, AUTOTRANSFUSION

Public Device Record Key

79205eb5-23f3-4e55-9c1a-ef9700200225

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

July 06, 2015

Package DI Number

38033178110526

Quantity per Package

40

Contains DI Package

18033178110522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX