PILLOW SENSOR,RESP,PHILIPS 989803168851

GUDID 00884838050761

INVIVO CORPORATION

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 00884838050761
• NIH Device Record Key: a4222f12-097c-4c1c-b94c-15a68dee78e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PILLOW SENSOR,RESP,PHILIPS
• Version Model Number: 989803168851
• Catalog Number: 989803168851
• Company DUNS: 013649151
• Company Name: INVIVO CORPORATION
• 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	00884838050761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041918

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: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-10-27

On-Brand Devices [PILLOW SENSOR,RESP,PHILIPS]

• 00884838050761: 989803168851
• 00884838103986: 989803168851