Respiguide Delivery System

GUDID 00857688007278

Respiguide Delivery System, 35 cm Outer Guide Catheter with 120 degree bend Distal shape; 65 cm Inner Angiographic Catheter with Straight Distal Shape

RESPICARDIA, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00857688007278
• NIH Device Record Key: a6c4b55a-db17-4454-8985-8b620a0aced8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Respiguide Delivery System
• Version Model Number: 7120-S
• Company DUNS: 027887663
• Company Name: RESPICARDIA, 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com
• Phone: +19525404471
• Email: mlynn@respicardia.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857688007278 [Primary]
GS1	10857688007275 [Package]; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130378

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-23
• Device Publish Date: 2018-04-30

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