Stryker Sustainability Solutions 4001

GUDID 57613327610579

STRYKER SUSTAINABILITY SOLUTIONS, INC.

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