989803100301

GUDID 00884838010024

Philips Medizin Systeme Böblingen GmbH

Gas-sampling/monitoring respiratory tubing, single-use

• Primary Device ID: 00884838010024
• NIH Device Record Key: 416528e2-cc45-4d30-af13-c6afc252e53c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803100301
• Catalog Number: 989803100301
• 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: 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
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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
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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
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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
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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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838010024 [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: 2017-07-26

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• 00884838126411 - Leads: 2025-07-24 Wireless PIM Leadwires for PageWriter TC Series Cardiographs, 10-lead, AAMI color-coding, 3mm needle
• 00884838126428 - Leads: 2025-07-24 Wireless PIM Leadwires for PageWriter TC Series Cardiographs,10-lead, IEC color-coding, 4mm banana
• 00884838114937 - NIBP Cuffs: 2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
• 00884838114951 - NIBP Cuffs: 2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
• 00884838114975 - NIBP Cuffs: 2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
• 00884838114999 - NIBP Cuffs: 2025-07-11 Neonatal Soft Single-Patient Cuff Size#2