989803128621

GUDID 00884838010277

Philips Medizin Systeme Böblingen GmbH

Pulse oximeter probe, reusable

• Primary Device ID: 00884838010277
• NIH Device Record Key: 445132eb-771e-4662-b3de-e9f0eecb9a82
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803128621
• Catalog Number: 989803128621
• 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: false
• Serial Number: true
• 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
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• Phone: +1(999)999-9999
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838010277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032979

FDA Product Code

• DQA: Oximeter

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: 2016-11-22

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

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• 00884838117204 - patient lead wire: 2026-01-26 Complete Lead Set for PageWriter TC Series Cardiographs, IEC Color Coded. Consisting of 2 arm leads (39"(1m)), 2 leg leads (41"
• 00884838117211 - patient lead wire: 2026-01-26 Long complete lead set for PageWriter TC Series Cardiographs, AAMI color coded. Consisting of 2 long arm leads (54" (1,37m)), 2
• 00884838117228 - patient lead wire: 2026-01-26 Long complete lead set for PageWriter TC Series Cardiographs, IEC color coded. Consisting of 2 long arm leads (54" (1,37m)), 2 l
• 00884838086678 - Masimo Sedline Module: 2026-01-23 Masimo SedLine Plug-in Module for IntelliVue Patient Monitors to connect the Masimo SedLine Measurement Device (989803203051)
• 00884838117259 - patient lead wire: 2026-01-23 Limb lead set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting of 2 arm leads (39",99cm), 2 leg leads
• 00884838117266 - patient lead wire: 2026-01-23 Long Limb lead set for PageWriter TC Series Cardiographs, AAMI and IEC color coded. Consisting of 2 long arm leads (54",1,37m),
• 00884838117235 - patient lead wire: 2025-12-23 Chest lead Set for PageWriter TC Series Cardiographs AAMI and IEC color coded, consisting of one 1 in 3 (Trident) Lead ( 28" (70