Catalog Number

4100

Brand Name

Atlanta BioMedical Model 4100

Version/Model Number

4100

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

-

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

K072603

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

6b7ac39c-bc1e-42c8-83be-4e1b77adf0a2

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

September 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-