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

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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

• 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
• 00884838115019 - NIBP Cuffs: 2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
• 00884838114913 - NIBP Cuffs: 2025-07-10 Neonatal Single-Patient NIBP Kit contains 50 Cuffs: 5 M1866B Size#1, 10 M1868B Size#2, 20 M1870B Size#3, 10 M1872B Size#4, 5 M18
• 00884838124066 - MR Patient Care Portal Remote Display # 5000: 2025-06-12 MR Patient Care Portal 5000
• 00884838111363 - MR Patient Care Expression Model MR400 MRI Patient Monitoring System: 2025-06-10 Expression Patient Monitor (MR400): 15 inch Widescreen Touchscreen interface, MRI Rating 5,000 gauss 4W/kg SAR 3.0T, 8-Hour Smar