ECHOGLO

GUDID 35019517091650

Smiths Medical ASD, Inc.

Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit

• Primary Device ID: 35019517091650
• NIH Device Record Key: ae8cacd8-1a30-4462-8f69-9138d3ee8b95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECHOGLO
• Version Model Number: 24-4122-01
• Company DUNS: 082005361
• Company Name: Smiths Medical ASD, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15019517091656 [Primary]
GS1	35019517091650 [Package]; Contains: 15019517091656; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K965017

FDA Product Code

• CAZ: Anesthesia conduction kit

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: 2020-09-23
• Device Publish Date: 2020-09-15

On-Brand Devices [ECHOGLO]

• 35019517091681: 24-4128-01
• 35019517091674: 24-4127-01
• 35019517091667: 24-4126-01
• 35019517091650: 24-4122-01