989803145671

GUDID 00884838073579

Philips Medizin Systeme Böblingen GmbH

Gas-sampling/monitoring respiratory tubing, single-use

• Primary Device ID: 00884838073579
• NIH Device Record Key: 16fffb68-1f1d-4dc9-9e91-1bc36c35eda0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803145671
• Catalog Number: 989803145671
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838073579 [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: 2019-08-21
• Device Publish Date: 2016-11-17

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

• 00884838128880 - Patient Information Center iX: 2026-03-17 Patient Information Center iX
• 00884838129214 - Care Assist: 2026-03-17 Care Assist
• 00884838129221 - Care Assist: 2026-03-17 Care Assist
• 00884838117877 - MR Patient Care Pediatric SpO2 Clip: 2026-03-17 Reusable SpO2 finger clip designed for use with the Quick Connect SPO2 Sensor (989803161991) - Sized for Pediatric patients
• 00884838117358 - patient lead wire: 2026-03-13 Std 10-lead Patient Cable IEC
• 00884838117273 - patient lead wire: 2026-03-12 Upgrade Kit 12-15/16 leads AAMI color coded for PageWriter TC 70. Consisting of 4 additional lead assy (33" (0,84m)), 6 shorting
• 00884838117280 - patient lead wire: 2026-03-12 Upgrade Kit 12-15/16 leads IECI color coded for PageWriter TC 70. Consisting of 4 additional lead assy (33", (0,84m)), 6 shortin
• 00884838117297 - patient lead wire: 2026-03-12 Long Upgrade Kit 12-15/16 leads AAMI color coded for PageWriter TC70. Consisting of 4 additional long lead assy (48", 1,22m)), 6