Catalog Number

DG2M-110-50S

Brand Name

Spectrum, Inc.

Version/Model Number

DG2M-230

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K852996,K852996

Product Code

FPB

Product Code Name

Filter, infusion line

Public Device Record Key

ea0943a6-62f0-4fe0-be09-11cbb3348b54

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 30, 2017

Package DI Number

00850301007594

Quantity per Package

50

Contains DI Package

00850301007587

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper