AccessGUDID - DEVICE: Cenorin (00852494007085)

GUDID

Device Identifier (DI) Information

Brand Name: Cenorin
Version or Model: 610HT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CENORIN, L.L.C.

Primary DI Number: 00852494007085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 157362497 *Terms of Use

Device Description: Washer-Pasteuerizer/High Level Disinfector

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):	No
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?
44555	Pasteurization water bath	A device usually in the form of a small heated water bath intended to be used to kill most infective agents on instruments by heating in water to 70? to 75? Celsius for a minimum of 20 minutes. This procedure is intended to provide disinfection for items where total sterility is not required.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDS	Device, Pasteurization, Hot Water

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183444	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: e2f6a1a0-6a4a-42eb-b946-6556991c6d0d
Public Version Date: July 23, 2021
Public Version Number: 1
DI Record Publish Date: July 15, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 253-395-2400
Email: CustomerService@cenorin.com

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