Catalog Number

-

Brand Name

APack Mini L,CS Mask Stan5

Version/Model Number

MP01686

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CAI

Product Code Name

Circuit, Breathing (W Connector, Adaptor, Y Piece)

Public Device Record Key

31c148f2-5ba0-4dbf-8a40-3088d0c0cf49

Public Version Date

October 21, 2020

Public Version Number

6

DI Record Publish Date

October 24, 2015

Package DI Number

04048675252092

Quantity per Package

10

Contains DI Package

04048675420941

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-