Pediatric Pneumograph - Non-Metallic w/10' Tubing - The Non-Metallic Pneumos consist of two plastic - LAFAYETTE INSTRUMENT COMPANY, INC.

Duns Number:005080650

Device Description: The Non-Metallic Pneumos consist of two plastic end pieces connected by a rubber convolute 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.

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More Product Details

Catalog Number

76513NM10K

Brand Name

Pediatric Pneumograph - Non-Metallic w/10' Tubing

Version/Model Number

76513NM10K

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IXO

Product Code Name

Synchronizer, Ecg / Respirator, Radiographic

Device Record Status

Public Device Record Key

690607cf-2467-44a9-81ad-12e86155b3ef

Public Version Date

September 08, 2021

Public Version Number

1

DI Record Publish Date

August 31, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LAFAYETTE INSTRUMENT COMPANY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21