Catalog Number

386-85

Brand Name

HUDSON RCI

Version/Model Number

IPN913755

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

K001213,K001213,K001213

Product Code

BTT

Product Code Name

HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Public Device Record Key

f77e37b6-4bb3-4c2a-a0a7-68ded5151e42

Public Version Date

September 18, 2019

Public Version Number

1

DI Record Publish Date

September 10, 2019

Package DI Number

34026704659624

Quantity per Package

1

Contains DI Package

14026704659620

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case