AccessGUDID - DEVICE: Citrajet (00660483201518)

GUDID

Device Identifier (DI) Information

Brand Name: Citrajet
Version or Model: 15 Gallon
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2015
Company Name: ALCONOX INC

Primary DI Number: 00660483201518
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001478726 *Terms of Use

Device Description: Cleaner for ultrasonic cleaning of medical devices

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?
58061	Instrument rinsing agent	A liquid substance with a neutral or acidic pH intended for the rinsing of medical/surgical instruments (e.g., specula, forceps) after machine cleaning and prior to full sterilization. It is typically a phosphoric acid (H3PO4) in an aqueous solution that neutralizes the alkaline residues from detergents and water (acidic rinse), or lubricants and drying activators (neutral rinse) and may be added, as specified by the manufacturer, to an automated washer. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLG	Cleaner, Ultrasonic, Medical Instrument

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 71c7a030-ae16-4816-b426-20e39a3e8ad6
Public Version Date: October 16, 2020
Public Version Number: 1
DI Record Publish Date: October 08, 2020

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: 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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