ECHOGLO

GUDID 35019517091650

Smiths Medical ASD, Inc.

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