989803103261

GUDID 00884838010291

Philips Medizin Systeme Böblingen GmbH

Pulse oximeter probe, reusable

• Primary Device ID: 00884838010291
• NIH Device Record Key: fb56ce75-2da5-4b42-bc81-687ec68f88df
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803103261
• Catalog Number: 989803103261
• Company DUNS: 314101143
• Company Name: Philips Medizin Systeme Böblingen GmbH
• 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: false
• Serial Number: true
• 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

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838010291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021300

FDA Product Code

• DSI: DETECTOR AND ALARM, ARRHYTHMIA

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-23

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

• 00884838114685 - NIBP Cuffs: 2025-04-01 Long-life reusable NIBP cuff/adult. Premium quality individual cuff w/fluid cap and instructions. For limb circum-ference 27.0-3
• 00884838114708 - NIBP Cuffs: 2025-04-01 Long-life reusable NIBP cuff/large adult Premium quality individual cuff w/fluid cap and instructions. For limb circumference 34
• 00884838114654 - NIBP Cuffs: 2025-03-31 Long-life reusable NIBP cuff/infant Premium quality individual cuff w/fluid cap & instructions; limb circumference 10.0-15cm. Po
• 00884838114661 - NIBP Cuffs: 2025-03-31 Long-life reusable NIBP cuff/pediatric. Premium quality individual cuff w/fluid cap and instructions. For limb circumference 14-
• 00884838114678 - NIBP Cuffs: 2025-03-31 Long-life reusable NIBP cuff/small adult Premium quality individual cuff w/fluid cap and instructions. For limb circumference 20
• 00884838114692 - NIBP Cuffs: 2025-03-31 Comfort Care Cuff, Adult Long (navy blue w/edge striping). Limb circumference 27-35cm. Reusable 2-piece cuff with removable blad
• 00884838114715 - NIBP Cuffs: 2025-03-31 Long-life reusable NIBP cuff/thigh. Premium quality individual cuff w/fluid cap and instructions. For limb circumference 42-54cm
• 00884838114722 - NIBP Cuffs: 2025-03-31 Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condition