Catalog Number

L-DNP

Brand Name

Loaner, Digital Newport

Version/Model Number

L-DNP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

October 15, 2199

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

-

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

K052335

Product Code

BSZ

Product Code Name

Gas-Machine, Anesthesia

Public Device Record Key

60b74a44-4e06-45d6-a127-458400f34944

Public Version Date

October 23, 2019

Public Version Number

1

DI Record Publish Date

October 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-