Catalog Number

-

Brand Name

INTER-THERM MINI PAEDIATRIC HMEF WITH LUER PORT - STERILE

Version/Model Number

1331000S

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

b24e7c4c-e1ad-4acd-9545-410a94c4a17a

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 06, 2021

Package DI Number

05030267109470

Quantity per Package

50

Contains DI Package

05030267109463

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-