AccessGUDID - DEVICE: Celerity (00724995201845)

GUDID

Device Identifier (DI) Information

Brand Name: Celerity
Version or Model: Incubator
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LCB046
Company Name: STERIS CORPORATION

Primary DI Number: 00724995201845
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 868205779 *Terms of Use
Previous DI: 00724995154257

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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46944	Test tube heater	An electrically-powered device used in the laboratory to hold and maintain at specific temperatures test tubes containing a fluid specimen (e.g., cell samples). The device typically contains several slots to hold test tubes upright, and its heating element is controlled electronically to reliably maintain a physiological temperature.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRC	Indicator, biological sterilization process

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171587	000
K190297	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f4bb73a1-cd17-4b2b-9bdc-9603972c73a8
Public Version Date: June 19, 2023
Public Version Number: 2
DI Record Publish Date: April 25, 2022