AccessGUDID - DEVICE: CER-2 (00677964021725)

GUDID

Device Identifier (DI) Information

Brand Name: CER-2
Version or Model: CER-2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 78399726
Company Name: MEDIVATORS INC.

Primary DI Number: 00677964021725
Issuing Agency: GS1
Commercial Distribution End Date: May 25, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use

Device Description: CER-2

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?
35012	Endoscope washer/disinfector	A mains electricity (AC-powered) unit intended to be used for the washing and/or disinfecting of endoscopes, and their accessories, with water or an appropriate disinfectant solution. It has built-in features to circulate a solution through the lumen (flushing) of the endoscope; some types may also have built-in drying features.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NVE	Washer, Cleaner, Automated, Endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K871712	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: ca78067f-6938-4c12-b9ef-9b3d1a4975e2
Public Version Date: May 26, 2022
Public Version Number: 6
DI Record Publish Date: September 20, 2016

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: +1(800)548-4873
Email: custserv@medivators.com

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