Catalog Number

-

Brand Name

MR Patient Care LoFlo CO2 with Airway Adapters (20)

Version/Model Number

P183291

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

Product Code

BZA

Product Code Name

Connector, Airway (Extension)

Public Device Record Key

e761ee42-0a50-4a52-8597-3c3aaf311db9

Public Version Date

July 20, 2021

Public Version Number

3

DI Record Publish Date

June 30, 2021

Package DI Number

10709078012720

Quantity per Package

20

Contains DI Package

00709078012723

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case