Catalog Number

AGM316-10, AGM316-50, AGM316-100

Brand Name

MediPines Single Patient Use Breathing Circuit

Version/Model Number

AGM316

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

K180902,K180902,K180902,K180902

Product Code

BZL

Product Code Name

Computer, Oxygen-Uptake

Public Device Record Key

8532f342-0cca-4c3f-8cb9-f2766f31698c

Public Version Date

March 23, 2020

Public Version Number

4

DI Record Publish Date

March 25, 2019

Package DI Number

00860001261523

Quantity per Package

5

Contains DI Package

00860001261516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-