989803151951

GUDID 00884838073609

Philips Medizin Systeme Böblingen GmbH

Patient monitoring system module, blood gas, transcutaneous

• Primary Device ID: 00884838073609
• NIH Device Record Key: 23877ff7-3c33-423f-8c95-8c4e01e85471
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803151951
• Catalog Number: 989803151951
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838073609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925910

FDA Product Code

• KLK: Monitor, oxygen, cutaneous, for infant not under gas anesthesia

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: 2017-02-14

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

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• 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