989803100311

GUDID 20884838010035

Philips Medizin Systeme Böblingen GmbH

Gas-sampling/monitoring respiratory tubing, single-use, non-sterile

• Primary Device ID: 20884838010035
• NIH Device Record Key: 67b34b01-ab16-4814-a474-34d9cf8af481
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803100311
• Catalog Number: 989803100311
• 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: 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
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	20884838010035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040917

FDA Product Code

• CBQ: ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)

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: 2017-02-01

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

• 00884838120563 - MR Patient Care Kit, Sample, Agents, 3160: 2025-05-29 KIT,SAMPLE,AGENTS,3160
• 00884838117839 - MR Patient Care Single Patch ECG Electrodes (25): 2025-05-29 QUADTRODE MRI ECG PAD,25/BOX
• 00884838117846 - MR Patient Care Multiple Patch ECG Electrodes (25): 2025-05-29 ELECTRODE, MRI ECG, QUADTRODE CV, 25/BOX
• 00884838117853 - MR Patient Care Neonatal ECG Electrodes (25): 2025-05-29 ELECTRODE, NEONATE MRI ECG, QUADTRODE CV, 25/BOX
• 00884838120532 - MR Patient Care Short Wide ECG 2.0 Cable AAMI: 2025-05-28 CAB,4 LD,CV MRI ECG,3160
• 00884838120549 - MR Patient Care Short Standard ECG 2.0 Cable AAMI: 2025-05-28 CAB,4 LD,MRI ECG,3160
• 00884838120693 - MR Patient Care Long Wide ECG 2.0 Cable AAMI: 2025-05-28 ECG Leadwire Set designed for use with the Expression MRI Patient Monitor when utlizing the system's Advanced ECG Gradient Filte
• 00884838120730 - MR Patient Care Long Extra Wide ECG 2.0 Cable AAMI: 2025-05-28 Advanced Apps ECG Cable for wireless ECG modules