Catalog Number

-

Brand Name

Aimsco

Version/Model Number

620

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

b7af3ba4-9b57-447f-ab7e-8894b66b6633

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 06, 2017

Package DI Number

DHT16202

Quantity per Package

10

Contains DI Package

DHT16201

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-