PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160 989803152791

GUDID 00884838045163

INVIVO CORPORATION

Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph Pneumograph

• Primary Device ID: 00884838045163
• NIH Device Record Key: 05658f4a-0c13-4cab-8478-398bb905a60b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160
• Version Model Number: 989803152791
• Catalog Number: 989803152791
• 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	00884838045163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090785

FDA Product Code

• MWI: MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT 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: 2016-10-27

On-Brand Devices [PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160]

• 00884838045163: 989803152791
• 00884838101449: 989803152791