Catalog Number

1M2009

Brand Name

FlowEase [Subcutaneous] Infusion Set

Version/Model Number

1M2009

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

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

K121092,K121092,K121092

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

ee7d0209-751a-4af3-ac8f-5e1039668629

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

September 28, 2016

Package DI Number

50642621029241

Quantity per Package

8

Contains DI Package

20642621029240

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper