BREEZE® XS APD - 6F X 10CM BREEZE® XS ALL PURPOSE DRAIN WITH - Medical Components, Inc.

Duns Number:038000253

Device Description: 6F X 10CM BREEZE® XS ALL PURPOSE DRAIN WITH LOCKING PIGTAIL SET

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More Product Details

Catalog Number

XSALPN0620S

Brand Name

BREEZE® XS APD

Version/Model Number

XSALPN0620S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

Yes

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 Details

Product Code

FGE

Product Code Name

Stents, drains and dilators for the biliary ducts

Device Record Status

Public Device Record Key

348f7870-14d8-4b0c-be76-1fdaef6e1475

Public Version Date

March 07, 2022

Public Version Number

1

DI Record Publish Date

February 26, 2022

Additional Identifiers

Package DI Number

50884908159603

Quantity per Package

20

Contains DI Package

30884908159609

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"MEDICAL COMPONENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 2560