PNEUMO NONMETALIC 10' LATEX FREE 76513NM10A

GUDID 00855170007140

The Non-Metallic Pneumos consist of two plastic end pieces connected by a rubber convoluted tube. The pieces are also connected internally by a rubber band. A connecting tube of various lengths is attached to the pneumograph assembly. These tube lengths can be 7, 10, 12, or 14 feet or 89 inches depending on customer specifications. The entire assembly is non-metallic so that that it can be used safely in an MRI environment. The Pneumograph is used as respiration sensor. The convoluted tube is attached around the upper or lower torso of the patient and is held in place with a Velcro strap. As the patient breathes, the tube expands and contracts which varies the pressure inside the tube in direct correlation to the breathing pattern. When attached to a pressure sensor, the breathing pattern of the patient can be sensed and recorded. The pneumograph is used as a gating sensor for MRI machines to sense the patient’s breathing pattern. The image acquisition of the MRI is triggered at the bottom of the patient’s breathing cycle when there is minimal movement of the chest cavity.

LAFAYETTE INSTRUMENT COMPANY, INC.

MRI system synchronizer

• Primary Device ID: 00855170007140
• NIH Device Record Key: aa09a791-4f54-4eb3-934d-82fd87cda89b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PNEUMO NONMETALIC 10' LATEX FREE
• Version Model Number: 76513NM10A
• Catalog Number: 76513NM10A
• Company DUNS: 005080650
• Company Name: LAFAYETTE INSTRUMENT COMPANY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in airtight bag and avoid continuous exposure to light
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855170007140 [Primary]

FDA Product Code

• IXO: Synchronizer, Ecg / Respirator, Radiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-20
• Device Publish Date: 2023-06-12