N/A 407453

GUDID 10841898130151

Swartz Braided Transseptal Guiding Introducer, 63 cm

INNOVATIVE HEALTH LLC

Vascular guide-catheter, reprocessed

• Primary Device ID: 10841898130151
• NIH Device Record Key: 52fbf8a4-012e-4377-b0bf-ec68289b5779
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: N/A
• Catalog Number: 407453
• Company DUNS: 015575953
• Company Name: INNOVATIVE HEALTH LLC
• 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: false
• Serial Number: true
• 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: 877-400-3740
• Email: regulatory@innovative-health.com
• Phone: 877-400-3740
• Email: regulatory@innovative-health.com
• Phone: 877-400-3740
• Email: regulatory@innovative-health.com
• Phone: 877-400-3740
• Email: regulatory@innovative-health.com
• Phone: 877-400-3740
• Email: regulatory@innovative-health.com
• Phone: 877-400-3740
• Email: regulatory@innovative-health.com
• Phone: 877-400-3740
• Email: regulatory@innovative-health.com
• Phone: 877-400-3740
• Email: regulatory@innovative-health.com
• Phone: 877-400-3740
• Email: regulatory@innovative-health.com
• Phone: 877-400-3740
• Email: regulatory@innovative-health.com
• Phone: 877-400-3740
• Email: regulatory@innovative-health.com
• Phone: 877-400-3740
• Email: regulatory@innovative-health.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841898130151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170311

FDA Product Code

• PNE: Reprocessed Catheter Introducer

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: 2020-09-04
• Device Publish Date: 2020-08-27

On-Brand Devices [N/A]

• 10841898122026: Radia Steerable Diagnostic EP Catheter, 7F
• 10841898128691: Torqr Diagnostic EP Catheter, 5F
• 10841898128639: Torqr Diagnostic EP Catheter, 6F
• 10841898128233: Catheter Interface Cable Response 5 ft 20/20 Black Pins
• 10841898128165: Catheter Interface Cable, Recording System, 3 ft 4/6 Green Pins
• 10841898126383: Inquiry Steerable Diagnostic EP Catheter 5F
• 10841898125393: Webster CS Uni-Directional Diagnostic EP Catheter 6F
• 10841898125300: Safire Catheter Extension Cable 10 ft 14 Black/9 Red Pins
• 10841898125294: Safire Catheter Extension Cable 5 ft 14 Black/9 Red Pins
• 10841898125232: Safire TX Cable - IBI Generator 1642 Catheter Interface Cable 8 ft 14 Black/14 Yellow pins
• 10841898125201: Response EP Extension Cable 5 ft 4 Red Pins
• 10841898125195: Response EP Extension Cable 5 ft 4 Grey Pins
• 10841898125171: Response EP Extension Cable 5 ft 4 Black Pins
• 10841898123795: Viking Soft Tip Diagnostic EP Catheter, 6F
• 10841898123757: Viking Soft Tip Diagnostic EP Catheter, 6F
• 10841898123160: Halo XP with Auto ID Diagnostic EP Catheter 7F
• 10841898123108: Livewire Steerable Diagnostic EP Catheter, 5F
• 10841898123016: Inquiry Steerable Diagnostic EP Catheter 7F
• 10841898122989: Inquiry Steerable Diagnostic EP Catheter 5F
• 10841898122965: Inquiry Steerable Diagnostic EP Catheter 5F
• 10841898122934: Inquiry Steerable Diagnostic EP Catheter 6F
• 10841898122927: Inquiry Steerable Diagnostic EP Catheter 6F
• 10841898122880: Inquiry Steerable Diagnostic EP Catheter 6F
• 10841898122866: Inquiry Steerable Diagnostic EP Catheter 6F
• 10841898122835: Inquiry Steerable Diagnostic EP Catheter 6F
• 10841898122828: Inquiry Steerable Diagnostic EP Catheter 6F
• 10841898122774: Inquiry Steerable Diagnostic EP Catheter 6F
• 10841898122736: Inquiry Steerable Diagnostic EP Catheter 6F
• 10841898122712: Inquiry Steerable Diagnostic EP Catheter 5F
• 10841898122705: Inquiry Steerable Diagnostic EP Catheter 5F
• 10841898122675: Inquiry Steerable Diagnostic EP Catheter 4F
• 10841898122644: Inquiry Steerable Diagnostic EP Catheter 5F
• 10841898122613: Inquiry Steerable Diagnostic EP Catheter 4F
• 10841898122583: Inquiry Steerable Diagnostic EP Catheter 4F
• 10841898122477: Surelink Catheter Interface Cable 4 ft 4 Red Pins
• 10841898122460: SureLink Catheter Interface Cable 4 ft Blue 4 Pins
• 10841898122446: QwikCable Catheter Interface Cable 6 ft
• 10841898122057: Radia Steerable Diagnostic EP Catheter, 7F
• 10841898122033: Radia Steerable Diagnostic EP Catheter, 7F
• 10841898121999: Radia Steerable Diagnostic EP Catheter, 7F
• 10841898121982: Radia Steerable Diagnostic EP Catheter, 7F
• 10841898121395: EP XT Steerable Diagnostic EP Catheter, 6F
• 10841898121333: EP XT Steerable Diagnostic EP Catheter, 6F
• 10841898121142: Webster Fixed Curve Diagnostic EP Catheter 6F
• 10841898120954: Webster Fixed Curve Diagnostic EP Catheter 5F
• 10841898119460: Viking Diagnostic EP Catheter, 6F
• 10841898119262: Viking Diagnostic EP Catheter, 5F
• 10841898118562: Viking Diagnostic EP Catheter, 5F
• 10841898117237: Dynamic XT Steerable Diagnostic EP Catheter, 6F
• 10841898117220: Dynamic XT Steerable Diagnostic EP Catheter, 6F