989803100341

GUDID 00884838010055

Philips Medizin Systeme Böblingen GmbH

Gas-sampling/monitoring respiratory tubing, single-use

• Primary Device ID: 00884838010055
• NIH Device Record Key: 95992d39-a7f3-4c8b-ae9e-40712d95528c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803100341
• Catalog Number: 989803100341
• 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: 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

• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• 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
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• 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
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• 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	00884838010055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040917

FDA Product Code

• CBQ: ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)

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: 2019-08-21
• Device Publish Date: 2017-01-19

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