XVIVO Click Adapter 19125

GUDID 07350069520302

Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.

Xvivo Perfusion AB

Surgical irrigation tubing set, single-use

• Primary Device ID: 07350069520302
• NIH Device Record Key: 41f0e0fb-c712-47cb-b673-e7385a8f30d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XVIVO Click Adapter
• Version Model Number: 19125
• Catalog Number: 19125
• Company DUNS: 559895730
• Company Name: Xvivo Perfusion AB
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350069520302 [Primary]

FDA Product Code

• NEP: System/Device, Pharmacy Compounding

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: 2019-04-23
• Device Publish Date: 2018-09-19

On-Brand Devices [XVIVO Click Adapter]

• 07350069520302: Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.
• 07350069520425: Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.