Catalog Number

-

Brand Name

Khaimi Concentrator, 0.33 mL

Version/Model Number

9001-33

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"

-

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

-

Product Code

HBQ

Product Code Name

Instrument, Clip Removal

Public Device Record Key

fa935863-5c5a-4f50-bedb-131a4623bd59

Public Version Date

July 10, 2019

Public Version Number

1

DI Record Publish Date

July 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-