Catalog Number

18103300

Brand Name

SU-VEID

Version/Model Number

18103300

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

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

K993995

Product Code

FRF

Product Code Name

Cleaner, Air, Medical Recirculating

Public Device Record Key

e20b58a5-8018-4a50-8c7a-b087ee68ad92

Public Version Date

May 31, 2021

Public Version Number

1

DI Record Publish Date

May 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-