BIOSITE / BIOSITE PLUS JR-009-HU

GUDID 00810083350844

JR-009-HU 300 psi High Pressure Needleless Neutral Valve

Sensimedical LLC

Intravenous administration tubing extension set

• Primary Device ID: 00810083350844
• NIH Device Record Key: 216e71b6-c5bc-455f-9980-6101deae6b68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOSITE / BIOSITE PLUS
• Version Model Number: JR-009-HU
• Catalog Number: JR-009-HU
• 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	00810083350837 [Primary]
GS1	00810083350844 [Package]; Contains: 00810083350837; Package: [250 Units]; In Commercial Distribution
GS1	00810083350851 [Package]; Package: [1000 Units]; In Commercial Distribution

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 [BIOSITE / BIOSITE PLUS]

• 00810083350844: JR-009-HU 300 psi High Pressure Needleless Neutral Valve
• 00810083350431: JR-009-TU 60 psi Transparent Needleless Neutral Valve