AccessGUDID - DEVICE: UF-CELLSHEATH (04987562433926)

GUDID

Device Identifier (DI) Information

Brand Name: UF-CELLSHEATH
Version or Model: BY074501
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYSMEX CORPORATION

Primary DI Number: 04987562433926
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690664461 *Terms of Use

Device Description: UF-CELLSHEATH is a sheath fluid for Sysmex Fully Automated Urine Particle Analyzers. This reagent is used in combination with other reagents to obtain a count of the target substance by means of the flow cytometry method. UF-CELLSHEATH is used as a system fluid for sample aspiration and as a washing fluid with Sysmex Fully Automated Urine Particle Digital Imaging 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):	Yes
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?
58237	Buffered sample diluent IVD	A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GIF	Diluent, Blood Cell

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
Storage Environment Temperature: between 2 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 20 Liter

Device Record Status

Public Device Record Key: c1c11d5a-8c2d-4921-b300-10646b212de0
Public Version Date: June 02, 2023
Public Version Number: 2
DI Record Publish Date: November 30, 2022