Pediatric Pneumograph - Non-Metallic w/10' Tubing 76513NM10K

GUDID 00855170007287

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 ID00855170007287
NIH Device Record Key690607cf-2467-44a9-81ad-12e86155b3ef
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediatric Pneumograph - Non-Metallic w/10' Tubing
Version Model Number76513NM10K
Catalog Number76513NM10K
Company DUNS005080650
Company NameLAFAYETTE INSTRUMENT COMPANY, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com
Phone765-423-1505
Emailbbrown@lafayetteinstrument.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in airtight bag and avoid continuous exposure to light

Device Identifiers

Device Issuing AgencyDevice ID
GS100855170007287 [Primary]

FDA Product Code

IXOSynchronizer, Ecg / Respirator, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-08
Device Publish Date2021-08-31