Catalog Number

1911-321

Brand Name

Epimed

Version/Model Number

1911-321

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051171,K051171

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Public Device Record Key

1f75c67d-fee9-4d64-bc97-8dac0391ece0

Public Version Date

August 09, 2018

Public Version Number

4

DI Record Publish Date

October 24, 2017

Package DI Number

10818788022100

Quantity per Package

10

Contains DI Package

00818788022103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case