DBK9

GUDID 07613327169331

STRYKER CORPORATION

External cuff/pad connection tubing

• Primary Device ID: 07613327169331
• NIH Device Record Key: e0e62f82-f6fe-41b4-8127-5133db9024f7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DBK9
• Catalog Number: DBK9
• Company DUNS: 078470558
• Company Name: STRYKER CORPORATION
• 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	07613327169331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100585

FDA Product Code

• DWJ: System, thermal regulating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-09-24

Devices Manufactured by STRYKER CORPORATION

• 07613327626391 - ThermaClear: 2025-04-14
• 07613327626407 - ThermaClear: 2025-04-14
• 07613327626469 - ThermaClear: 2025-04-14
• 07613327666601 - XpeditionTM Powered Stair Chair: 2025-03-31 Make to Stock- High Config (Grooved Tracks)
• 07613327639032 - Broadway System: 2025-03-20
• 07613327639049 - Broadway System: 2025-03-20
• 07613327648515 - Surpass Elite: 2025-03-17 Flow Diverter System
• 07613327648522 - Surpass Elite: 2025-03-17 Flow Diverter System