Catalog Number

900016

Brand Name

SAFIRA

Version/Model Number

SAFIRA Syringe

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

K153599,K153599

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

709858db-37f0-48e9-a49b-971997f305a3

Public Version Date

April 28, 2020

Public Version Number

1

DI Record Publish Date

April 20, 2020

Package DI Number

35060727270038

Quantity per Package

20

Contains DI Package

05060727270037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box