Catalog Number

27497-FRU

Brand Name

Automatic Manifold, Digi-Flo

Version/Model Number

27497-FRU

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 31, 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"

-

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

6add2902-eded-4a40-9ee7-ddfbaa7c33cd

Public Version Date

October 01, 2018

Public Version Number

1

DI Record Publish Date

August 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-