UF II PACK-SED

GUDID 84987562408388

UFII PACK -SED is a diluent for Sysmex fully automated urine particle analyzers, and is intended for use only in conjunction with UFII SEARCH -SED. UFII PACK -SED dilutes the aspirated sample for the determination of the parameters, Red Blood Cell (RBC), White Blood Cell (WBC), Epithelial Cells (EC) and Casts (CAST) count, by fluorescence flow cytometry method.

SYSMEX CORPORATION

Buffered sample diluent IVD, automated/semi-automated system

• Primary Device ID: 84987562408388
• NIH Device Record Key: c9d27de1-a7be-4363-b548-5e5d53e4338b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UF II PACK-SED
• Version Model Number: 06401615
• Company DUNS: 690664461
• Company Name: SYSMEX CORPORATION
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com

Device Dimensions

• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter
• Total Volume: 2.1 Liter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987562408382 [Primary]
GS1	84987562408388 [Unit of Use]

FDA Product Code

• GIF: Diluent, Blood Cell

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [UF II PACK-SED]

• 80664369999861: Diluent for Sysmex fully automated urine particle analyzers
• 84987562408388: UFII PACK -SED is a diluent for Sysmex fully automated urine particle analyzers, and is intended