Surgiphor 910100

GUDID 50382909101008

Surgiphor/Surgirinse Sterile Wound Irrigation System

CAREFUSION 2200, INC

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• Primary Device ID: 50382909101008
• NIH Device Record Key: 72bae79e-740d-4aab-a666-90bf20777787
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgiphor
• Version Model Number: 910100
• Catalog Number: 910100
• Company DUNS: 832696038
• Company Name: CAREFUSION 2200, INC
• 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: true
• 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

Customer Support Contacts

• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com
• Phone: +1(844)823-5433
• Email: Customer_Support@BD.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382909101003 [Primary]
GS1	50382909101008 [Package]; Contains: 00382909101003; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202071

FDA Product Code

• FQH: LAVAGE, JET

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: 2021-05-20
• Device Publish Date: 2021-05-12

On-Brand Devices [Surgiphor]

• 50382909101008: Surgiphor/Surgirinse Sterile Wound Irrigation System
• 50382909101107: Surgiphor Antimicrobial Irrigation System