AccessGUDID - DEVICE: CeroFrict (04897129990000)

GUDID

Device Identifier (DI) Information

Brand Name: CeroFrict
Version or Model: SML001-PT12
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SML Med-Tech Solutions Limited

Primary DI Number: 04897129990000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687239367 *Terms of Use

Device Description: Air Water Channel Cleaning Adapter

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:	Yes
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?
66650	Endoscope flushing/rinsing sink system	An electrically-powered assembly of devices intended to be used to flush and rinse endoscopes for pre-cleaning. It is intended to be connected to hot and cold water supplies and includes a sink with conventional style taps to facilitate pre-cleaning the external portion of the endoscopes, and a series of fluid lines for flushing each endoscope channel.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNL	Accessories, Cleaning Brushes, For Endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 2bc74e4f-7685-44f2-aaba-eb9f120a8208
Public Version Date: May 15, 2023
Public Version Number: 1
DI Record Publish Date: May 05, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
14897129990007	150	04897129990000		In Commercial Distribution
24897129990004	4	14897129990007		In Commercial Distribution

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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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