AcQRate Dx Fixed Curve Catheter 460644

GUDID 04260090928851

VascoMed GmbH

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• Primary Device ID: 04260090928851
• NIH Device Record Key: 14bb64fe-250b-449c-92a7-f423babf6066
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcQRate Dx Fixed Curve Catheter
• Version Model Number: 4J 6F 5 mm
• Catalog Number: 460644
• Company DUNS: 322983446
• Company Name: VascoMed GmbH
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260090928851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201445

FDA Product Code

• DRF: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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: 2021-11-01
• Device Publish Date: 2021-10-22

On-Brand Devices [AcQRate Dx Fixed Curve Catheter]

• 04260090928967: 10J CS 6F 2-8-2 mm
• 04260090928950: 10J CS 6F 2-5-2 mm
• 04260090928943: 10J 6F 5 mm
• 04260090928936: 10J Sp 5F 2-8-2 mm
• 04260090928929: 10J Sp 5F 2-5-2 mm
• 04260090928912: 5J 6F 5-5-5-280 mm
• 04260090928905: 4M 6F 5 mm
• 04260090928899: 4C 6F 5 mm Soft Tip
• 04260090928882: 4C 6F 5 mm
• 04260090928875: 4D 6F 5 mm
• 04260090928868: 4J 6F 5 mm Soft Tip
• 04260090928851: 4J 6F 5 mm
• 04260090928783: 4 HIS 5F 5 mm
• 04260090928776: 4C 5F 2-5-2 mm
• 04260090928769: 4J Sp 5F 2-5-2 mm
• 04260090928752: 4J Sp 100 cm 5F 2-5-2 mm
• 04260090928745: 4J Sp 100 cm 5F 5 mm
• 04260090928738: 4J Sp 5F 2 mm
• 04260090928721: 4J Sp 4F 2-5-2 mm
• 04260090928714: 4J Sp 4F 5 mm