Hemashield M002000196270

GUDID 00384401018827

Hemashield Woven Double Velour Cardiovascular Fabric

INTERVASCULAR SAS

Cardiovascular patch, animal-derived

• Primary Device ID: 00384401018827
• NIH Device Record Key: f37b26d3-6648-4300-b961-2e2566c493c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemashield
• Version Model Number: M002000196270
• Catalog Number: M002000196270
• Company DUNS: 382174019
• Company Name: INTERVASCULAR SAS
• 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: true
• Manufacturing Date: true
• 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: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com

Device Dimensions

• Width: 5.1 Centimeter
• Width: 5.1 Centimeter
• Length: 15.2 Centimeter
• Width: 5.1 Centimeter
• Length: 15.2 Centimeter
• Width: 5.1 Centimeter
• Length: 15.2 Centimeter
• Width: 5.1 Centimeter
• Length: 15.2 Centimeter
• Width: 5.1 Centimeter
• Length: 15.2 Centimeter
• Width: 5.1 Centimeter
• Length: 15.2 Centimeter
• Width: 5.1 Centimeter
• Length: 15.2 Centimeter
• Width: 5.1 Centimeter
• Length: 15.2 Centimeter
• Width: 5.1 Centimeter
• Length: 15.2 Centimeter
• Width: 5.1 Centimeter
• Length: 15.2 Centimeter
• Width: 5.1 Centimeter
• Length: 15.2 Centimeter
• Width: 5.1 Centimeter
• Length: 15.2 Centimeter
• Width: 5.1 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Controlled Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Controlled Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384401018827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955349

FDA Product Code

• DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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: 2015-11-11

On-Brand Devices [Hemashield]

• 00384401514428: Hemashield Platinum Woven ThoracoAbdominal 4 Branch Double Velour Vascular Graft with Graft Size
• 00384401514404: Hemashield Platinum Woven ThoracoAbdominal 4 Branch Double Velour Vascular Graft with Graft Size
• 00384401514381: Hemashield Platinum Woven ThoracoAbdominal 4 Branch Double Velour Vascular Graft with Graft Size
• 00384401018827: Hemashield Woven Double Velour Cardiovascular Fabric
• 00384401018810: Hemashield Woven Double Velour Cardiovascular Fabric
• 00384401018803: Hemashield Woven Double Velour Cardiovascular Fabric
• 00384401018797: Hemashield Platinum Woven ThoracoAbdominal 4 Branch Double Velour Vascular Graft with Graft Size
• 00384401018780: Hemashield Platinum Woven ThoracoAbdominal 4 Branch Double Velour Vascular Graft with Graft Size
• 00384401018773: Hemashield Platinum Woven ThoracoAbdominal 4 Branch Double Velour Vascular Graft with Graft Size
• 00384401018766: Hemashield Platinum Woven ThoracoAbdominal 4 Branch Double Velour Vascular Graft with Graft Size
• 00384401018759: Hemashield Platinum Woven 3 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018742: Hemashield Platinum Woven 3 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018735: Hemashield Platinum Woven Angled 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Si
• 00384401018728: Hemashield Platinum Woven Angled 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Si
• 00384401018711: Hemashield Platinum Woven Angled 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Si
• 00384401018704: Hemashield Platinum Woven Angled 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Si
• 00384401018698: Hemashield Platinum Woven 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018674: Hemashield Platinum Woven 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018667: Hemashield Platinum Woven 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018650: Hemashield Platinum Woven 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018643: Hemashield Platinum Woven 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018636: Hemashield Platinum Woven 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018629: Hemashield Platinum Woven 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018612: Hemashield Platinum Woven 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018605: Hemashield Platinum Woven 1 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018599: Hemashield Platinum Woven 1 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018582: Hemashield Platinum Woven 1 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018575: Hemashield Platinum Woven 1 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018568: Hemashield Platinum Woven 1 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018551: Hemashield Platinum Woven 1 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018544: Hemashield Platinum Woven 1 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018537: Hemashield Platinum Woven 1 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Acc
• 00384401018520: Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018513: Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018506: Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018490: Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018483: Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018476: Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018469: Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018452: Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018445: Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018438: Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018421: Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018414: Hemashield Platinum Woven Straight Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018407: Hemashield Platinum Woven Straight Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018391: Hemashield Platinum Woven Straight Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018384: Hemashield Platinum Woven Straight Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018377: Hemashield Platinum Woven Straight Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018360: Hemashield Platinum Woven Straight Double Velour Vascular Graft with Graft Sizer Accessory
• 00384401018353: Hemashield Platinum Woven Straight Double Velour Vascular Graft with Graft Sizer Accessory