Celerity - The Celerity HP Incubator was designed - STERIS CORPORATION

Duns Number:868205779

Device Description: The Celerity HP Incubator was designed exclusively to incubate and read activated Celerity The Celerity HP Incubator was designed exclusively to incubate and read activated Celerity 20 HP Biological Indicators.

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More Product Details

Catalog Number

LCB046

Brand Name

Celerity

Version/Model Number

Incubator

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171587,K190297,K171587,K190297

Product Code Details

Product Code

FRC

Product Code Name

Indicator, biological sterilization process

Device Record Status

Public Device Record Key

f4bb73a1-cd17-4b2b-9bdc-9603972c73a8

Public Version Date

May 03, 2022

Public Version Number

1

DI Record Publish Date

April 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERIS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1528
2 A medical device with a moderate to high risk that requires special controls. 1557