Catalog Number

-

Brand Name

XTRA

Version/Model Number

PROCEDURE SET BX/55

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

Product Code

CAC

Product Code Name

APPARATUS, AUTOTRANSFUSION

Public Device Record Key

a7f86bbe-0307-4f5b-871d-a3a74feb4cd7

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

July 06, 2015

Package DI Number

38033178110779

Quantity per Package

3

Contains DI Package

08033178110778

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX