989803103391

GUDID 00884838001411

Philips Medizin Systeme Böblingen GmbH

Intrapartum pressure monitoring catheter

• Primary Device ID: 00884838001411
• NIH Device Record Key: 0a8946d6-aca4-48ed-8462-7119d2053bcf
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803103391
• Catalog Number: 989803103391
• 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
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• 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	00884838001411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140535

FDA Product Code

• DSA: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

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: 2017-01-23

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

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• 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