WOLF-PACK / BIOSITE / BIOSITE PLUS BI8500

GUDID 00810083350370

BI8500 60 psi Transparent Needleless Neutral Valve

Sensimedical LLC

Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set

• Primary Device ID: 00810083350370
• NIH Device Record Key: ecb39251-f70a-4f32-b68c-4d1ec9b522bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WOLF-PACK / BIOSITE / BIOSITE PLUS
• Version Model Number: BI8500
• Catalog Number: BI8500
• 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	00810083350363 [Package]; Package: [1000 Units]; In Commercial Distribution
GS1	00810083350370 [Package]; Contains: 00810083350820; Package: [100 Units]; In Commercial Distribution
GS1	00810083350820 [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