RH-Pro9-230V - High Velocity Hot Air Sterilizer - 230V - CPAC EQUIPMENT, INC.

Duns Number:601985976

Device Description: High Velocity Hot Air Sterilizer - 230V

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More Product Details

Catalog Number

-

Brand Name

RH-Pro9-230V

Version/Model Number

RH-Pro9-230V

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K881371

Product Code Details

Product Code

KMH

Product Code Name

Sterilizer, Dry Heat

Device Record Status

Public Device Record Key

7eb78df4-9f8d-4d17-abb5-a5e8cf768d3d

Public Version Date

October 09, 2020

Public Version Number

1

DI Record Publish Date

October 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CPAC EQUIPMENT, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 28