AccessGUDID - DEVICE: UF II PACK-BAC (04987562408399)

GUDID

Device Identifier (DI) Information

Brand Name: UF II PACK-BAC
Version or Model: 06401712
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYSMEX CORPORATION

Primary DI Number: 04987562408399
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 690664461 *Terms of Use

Device Description: UFII PACK -BAC is a diluent to analyze bacteria in urine for determination of the bacterial count with the Sysmex Fully Automated Urine Particle Analyzers UF-1000i and UF-500i.

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: 2.1 Liter

Device Record Status

Public Device Record Key: 64a5c203-4d3f-42df-abb8-c4d087e3c7c3
Public Version Date: June 02, 2023
Public Version Number: 2
DI Record Publish Date: November 30, 2022