Odyssey Micro Catheter

GUDID 00857834006605

HERAEUS MEDICAL COMPONENTS, LLC

Peripheral vascular infusion catheter

• Primary Device ID: 00857834006605
• NIH Device Record Key: e78ed9af-1700-47d0-b0de-009c692bafa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Odyssey Micro Catheter
• Version Model Number: OMC-007
• Company DUNS: 080645456
• Company Name: HERAEUS MEDICAL COMPONENTS, 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857834006605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170664

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2019-04-09
• Device Publish Date: 2018-03-12

On-Brand Devices [Odyssey Micro Catheter]

• 00857834006933: OMC003
• 00857834006605: OMC-007