WOLF-PACK / BIOSITE / BIOSITE PLUS BI8000

GUDID 00810083350257

BI8000 Biosite Plus 60 psi Transparent Needleless Neutral Valve

Sensimedical LLC

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• Primary Device ID: 00810083350257
• NIH Device Record Key: 45761781-8579-400c-8dbb-c18d21593c18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WOLF-PACK / BIOSITE / BIOSITE PLUS
• Version Model Number: BI8000
• Catalog Number: BI8000
• Company DUNS: 117526048
• Company Name: Sensimedical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810083350240 [Package]; Package: [1000 Units]; In Commercial Distribution
GS1	00810083350257 [Package]; Contains: 00810083350813; Package: [100 Units]; In Commercial Distribution
GS1	00810083350813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121511

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-12
• Device Publish Date: 2024-01-04

On-Brand Devices [WOLF-PACK / BIOSITE / BIOSITE PLUS]

• 00810083350370: BI8500 60 psi Transparent Needleless Neutral Valve
• 00810083350257: BI8000 Biosite Plus 60 psi Transparent Needleless Neutral Valve
• 00810083350400: BI8504 Opaque Biosite Plus Neutral Pressure Needleless Valve w/14" Microbore Extension
• 00810083350394: BI8002 Clear Biosite Plus Neutral Pressure Needleless Valve w/8" Microbore Extension
• 00810083350387: BI8502 Opaque Biosite Plus Neutral Pressure Needless Valve w/8" Microbore Extension
• 00810083350417: BI8004 Clear Biosite Plus Neutral Pressure Needless Valve w/14" Microbore Extension