989803160371

GUDID 00884838007956

Philips Medical Systems

Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor

• Primary Device ID: 00884838007956
• NIH Device Record Key: bcbe783a-6de2-4007-822a-c611dc0a44b9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803160371
• Catalog Number: 989803160371
• Company DUNS: 078628040
• Company Name: Philips Medical Systems
• 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	00884838007956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150310

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

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: 2017-03-21

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• 20884838013524 - NA: 2021-10-01
• 20884838091782 - Microstream Advance Adult Oral-Nasal CO2 Filter Line: 2021-08-02
• 20884838091829 - Microstream Advance Adult-Intermediate Bite Block CO2 Filter Line: 2021-08-02
• 20884838091836 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line: 2021-08-02
• 20884838091850 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line: 2021-08-02