BCI

GUDID 15019517043051

Smiths Medical ASD, Inc.

Pulse oximeter probe, reusable

• Primary Device ID: 15019517043051
• NIH Device Record Key: 93cc9a3d-d1ab-40d9-b166-354757ac5c3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BCI
• Version Model Number: 3419
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	15019517043051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991410

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-10
• Device Publish Date: 2019-08-13

On-Brand Devices [BCI]

• 10610586039676: WW1018Y
• 10610586039645: WW1018B
• 10610586039669: WW1018R
• 10610586039652: WW1018G
• 15019517043051: 3419
• 15019517059199: 3311