Catalog Number

-

Brand Name

XTRA

Version/Model Number

PROCEDURE SET TX/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

03ec8be5-230d-42be-8297-d27d6cc00b83

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

July 06, 2015

Package DI Number

38033178110052

Quantity per Package

3

Contains DI Package

08033178110051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX