989803145681

GUDID 10884838073583

Philips Medizin Systeme Böblingen GmbH

Microbial medical gas filter, single-use

• Primary Device ID: 10884838073583
• NIH Device Record Key: 35a0b5d0-302b-44b9-a0dd-b3c9cacd3603
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803145681
• Catalog Number: 989803145681
• Company DUNS: 314101143
• Company Name: Philips Medizin Systeme Böblingen GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838073586 [Unit of Use]
GS1	10884838073583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151681

FDA Product Code

• CBS: ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)

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: 2020-09-22
• Device Publish Date: 2017-03-07

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

• 00884838117174 - NOUN: 2025-05-15 Electrode,limb clamp Icon/C400 4/bx
• 00884838127432 - Care Assist: 2025-05-14 Care Assist
• 00884838127449 - Care Assist: 2025-05-14 Care Assist
• 00884838114807 - NIBP Cuffs: 2025-04-09 Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condition
• 00884838114869 - NIBP Cuffs: 2025-04-09 Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condition
• 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