intelliPATH Plus

GUDID 00847627033031

BIOCARE MEDICAL LLC

Microscope slide stainer IVD

• Primary Device ID: 00847627033031
• NIH Device Record Key: c722e91c-2915-46ae-b2e4-02e3f6390ffa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: intelliPATH Plus
• Version Model Number: IPPLS0001INTL-R
• Company DUNS: 806617825
• Company Name: BIOCARE MEDICAL LLC
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627033031 [Primary]

FDA Product Code

• KPA: Slide Stainer, 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: 2024-01-11
• Device Publish Date: 2024-01-03

On-Brand Devices [intelliPATH Plus ]

• 00847627032768: IPPLS0001US-R
• 00847627032751: IPPLS0001US
• 00847627033031: IPPLS0001INTL-R
• 00847627032775: IPPLS0001INTL