ASP6025 S China 14049559088

GUDID 04049188210791

The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Infiltration with intermedium • Paraffin infiltration of histological tissue specimens. The ASP6025 S can be used as medical IVD product. The improved features of the ASP6025 S are the combination of: • Reduced processing time • Easier reagent exchange • Monitoring the ethanol quality by density measurement as well as the • Ability to replace xylene, a substance that is hazardous (including to the health), with special process protocols. The instrument has been designed so that it is safe to use by the operator as well as for processing specimens. However, the prerequisite for this is that it is operated according to these Instructions for Use.

Leica Biosystems Nussloch GmbH

Tissue processor IVD, automated/semi-automated

• Primary Device ID: 04049188210791
• NIH Device Record Key: b77493cb-fc2f-4e43-a2d1-51555552b133
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASP6025 S China
• Version Model Number: 000000014049559088
• Catalog Number: 14049559088
• Company DUNS: 315539452
• Company Name: Leica Biosystems Nussloch GmbH
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com
• Phone: +4962241430
• Email: CHS.support@LeicaBiosystems.com

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
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• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04049188210791 [Primary]

FDA Product Code

• IEO: PROCESSOR, TISSUE, AUTOMATED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-09-16
• Device Publish Date: 2019-07-05

Devices Manufactured by Leica Biosystems Nussloch GmbH

• 04049188210777 - ASP6025 S 230V/50-60Hz: 2022-09-16 The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydra
• 04049188210784 - ASP6025 S 120V/50-60Hz: 2022-09-16 The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydra
• 04049188210791 - ASP6025 S China: 2022-09-16The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Infiltration with intermedium • Paraffin infiltration of histological tissue specimens. The ASP6025 S can be used as medical IVD product. The improved features of the ASP6025 S are the combination of: • Reduced processing time • Easier reagent exchange • Monitoring the ethanol quality by density measurement as well as the • Ability to replace xylene, a substance that is hazardous (including to the health), with special process protocols. The instrument has been designed so that it is safe to use by the operator as well as for processing specimens. However, the prerequisite for this is that it is operated according to these Instructions for Use.
• 04049188210791 - ASP6025 S China: 2022-09-16 The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydra
• 04049188216397 - HistoCore PEGASUS: 2021-11-10 The HistoCore PEGASUS is an automated tissue processor specifically designed for fixation, dehydration, infiltration with interm
• 04049188217769 - HistoCore PEGASUS Plus: 2021-11-10 The HistoCore PEGASUS Plus is an automated tissue processor specifically designed for fixation, dehydration, infiltration with i
• 04049188003102 - Leica TP1020 VF/accessories: 2019-01-04 The instrument has been designed so that it is safe to use by the operator as well as for processing speci-mens—provided that
• 04049188003119 - Leica TP1020 F /accessories: 2019-01-04 The instrument has been designed so that it is safe to use by the operator as well as for processing speci-mens—provided that
• 04049188041326 - Leica TS5015 - Transfer Station: 2019-01-04 Leica Biosystems Accessory