HP300Plus Automatic Tissue Processor

GUDID 06971182570947

Dakewe (Shenzhen) Medical Equipment Co., Ltd.

Tissue processor IVD, automated

• Primary Device ID: 06971182570947
• NIH Device Record Key: b78977ad-9076-425e-b828-4485eb82af44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HP300Plus Automatic Tissue Processor
• Version Model Number: HP300Plus
• Company DUNS: 554456618
• Company Name: Dakewe (Shenzhen) Medical Equipment Co., Ltd.
• Device Count: 1
• DM Exempt: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971182570947 [Primary]

FDA Product Code

• IEO: Processor, Tissue, Automated

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: 2022-06-14
• Device Publish Date: 2022-06-06

Devices Manufactured by Dakewe (Shenzhen) Medical Equipment Co., Ltd.

• 06971182570978 - MT1 Rotary Microtome: 2022-06-15
• 06971182570947 - HP300Plus Automatic Tissue Processor: 2022-06-14
• 06971182570947 - HP300Plus Automatic Tissue Processor: 2022-06-14
• 06971182570015 - DP260 slide stainer: 2020-08-10
• 06971182570046 - HP300 Automatic Tissue Processor: 2020-08-10
• 06971182570084 - LS-2065 Rotary Microtome: 2020-08-10
• 06971182570145 - 2065A Auto Microtome: 2020-08-10
• 06971182570183 - DP360 slide stainer: 2020-08-10
• 06971182570190 - CS500 Glass Coverslipper: 2020-08-10