Stryker Sustainability Solutions 4001

GUDID 57613327610579

STRYKER SUSTAINABILITY SOLUTIONS, INC.

Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed Pulse oximeter probe, reprocessed

• Primary Device ID: 57613327610579
• NIH Device Record Key: fb7f5c4f-444c-48a9-8cf1-c1c3a57b9c64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stryker Sustainability Solutions
• Version Model Number: 4001
• Catalog Number: 4001
• Company DUNS: 020198912
• Company Name: STRYKER SUSTAINABILITY SOLUTIONS, 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: false
• 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: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com

Device Dimensions

• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch
• Length: 2.43 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327610574 [Primary]
GS1	57613327610579 [Package]; Contains: 07613327610574; Package: case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222019

FDA Product Code

• NLF: Oximeter, reprocessed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-15
• Device Publish Date: 2023-02-07

On-Brand Devices [Stryker Sustainability Solutions]

• 57613327610579: 4001
• 57613327610562: 4002
• 57613327610555: 4003
• 37613327610544: 4000