VAMP Jr VJ0095

GUDID 50690103199661

Blood Management System

Edwards Lifesciences LLC

Arterial blood sampling kit

• Primary Device ID: 50690103199661
• NIH Device Record Key: 917693fc-d785-4713-aaf2-6fe260b15d9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VAMP Jr
• Version Model Number: VJ0095
• Catalog Number: VJ0095
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 26 Inch
• Length: 26 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103199666 [Primary]
GS1	50690103199661 [Package]; Contains: 00690103199666; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896819

FDA Product Code

• KRA: Catheter, Continuous Flush

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-12

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