989803151961

GUDID 00884838010000

Philips Medizin Systeme Böblingen GmbH

Patient monitoring system module, blood gas, transcutaneous

• Primary Device ID: 00884838010000
• NIH Device Record Key: fee553ce-6605-4d13-a6ee-2c43bd03724e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803151961
• Catalog Number: 989803151961
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00884838010000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925910

FDA Product Code

• KLK: Monitor, oxygen, cutaneous, for infant not under gas anesthesia

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: 2017-01-18

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