DBK35CE

GUDID 07613327322576

STRYKER CORPORATION

External cuff/pad connection tubing

• Primary Device ID: 07613327322576
• NIH Device Record Key: de153a6a-ad4d-4570-a1ca-730ddc1d6030
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DBK35CE
• Catalog Number: DBK35CE
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327322576 [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

• 07613327419252 - Patient Helper: 2024-12-23
• 37613327556651 - Neptune: 2024-12-23 SafeAir 125mm Suction Sleeve, Non-Sterile
• 07613327643879 - Iconix: 2024-12-19 Iconix DC Guide for 2.3mm Anchor
• 07613327643886 - Iconix: 2024-12-19 Iconix DC Obturator for 2.3 Anchor
• 07613327644067 - Neptune: 2024-12-16 V2 SPECIMEN COLLECTION MANIFOLD
• 07613327262469 - VBOSS: 2024-12-10 ENDPLATE TIP SMALL
• 07613327262483 - VBOSS: 2024-12-10 ENDPLATE TIP LARGE
• 07613327262506 - VBOSS: 2024-12-10 ENDPLATE TIP OFFSET