AccessGUDID - DEVICE: Ninjo (05056097335087)

GUDID

Device Identifier (DI) Information

Brand Name: Ninjo
Version or Model: FG0C023LAUS0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Arjohuntleigh AB

Primary DI Number: 05056097335087
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355804758 *Terms of Use

Device Description: Ninjo flusher disinfector, FD1600

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?
35318	Bedpan/ancillary utensil washer-disinfector (thermal)	An electrically-powered unit designed to both wash (remove organic debris, dirt, stains) and thermally disinfect (destroy microorganisms) reusable devices such as bedpans, urine bottles, suction bottles, emesis basins (kidney bowls), handwash basins and similar reusable devices. The device includes an internal chamber containing baskets/racks onto which the medical devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals, long-term care facilities, nursing homes and healthcare centres.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLH	Washer Of Body Waste Receptacles

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e18666f0-7d97-4d0b-ae2c-4ea61dd7ad24
Public Version Date: October 18, 2023
Public Version Number: 3
DI Record Publish Date: August 03, 2022

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

[?]

No Customer Contact currently defined

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