CELLPACK DST

GUDID 00664369000264

Concentrated diluent for use in hematology analyzers

SYSMEX CORPORATION

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Primary Device ID	00664369000264
NIH Device Record Key	28dee1f6-8273-4f84-b997-bc5b02267053
Commercial Distribution Status	In Commercial Distribution
Brand Name	CELLPACK DST
Version Model Number	DST-300A
Company DUNS	690664461
Company Name	SYSMEX CORPORATION
Device Count	1
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	true
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)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com
Phone	+1(888)879-7639
Email	crc@sysmex.com

Device Dimensions

Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 Liter
Total Volume	20 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
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	00664369000264 [Primary]

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	2022-11-14
Device Publish Date	2022-11-04

On-Brand Devices [CELLPACK DST]

00664369000264	Concentrated diluent for use in hematology analyzers
14987562422941	CELLPACK DST is a concentrated diluent for use in Sysmex Automated Hematology Analyzers and othe
04987562422937	CELLPACK DST is a concentrated diluent for use in Sysmex Automated Hematology Analyzers and othe
04987562422920	CELLPACK DST is a concentrated diluent for use in Sysmex Automated Hematology Analyzers and othe