Catalog Number

-

Brand Name

Magellan Complete One Source Kit

Version/Model Number

AMS316

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

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

-

Product Code Name

-

Public Device Record Key

71871350-825d-4114-9497-2b20dbe2ae96

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

March 04, 2020

Package DI Number

M896AMS3161

Quantity per Package

5

Contains DI Package

M896AMS3160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-