"Pediatric Pneumograph - Non-Metallic w/89"" Tubing"

Primary DI
00855170007331
Brand
"Pediatric Pneumograph - Non-Metallic w/89"" Tubing"
Company
LAFAYETTE INSTRUMENT COMPANY, INC.
Model
76513NM89K
Catalog number
76513NM89K
Device description
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.
Published
2021-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IXOSynchronizer, Ecg / Respirator, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXOSynchronizer, Ecg / Respirator, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855170007331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855170007331008551700073318551700073310855170007331

GMDN Terms#

Term, Definition table
TermDefinition
MRI system synchronizerA physiological monitoring unit used as a component of a diagnostic magnetic resonance imaging (MRI) system, that produces a signal which enables image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient's respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic MRI applications. It is sometimes referred to as a gated imaging accessory or trigger.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00Store in airtight bag and avoid continuous exposure to light

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
765-423-1505bbrown@lafayetteinstrument.com

Regulatory Flags#

DUNS number
005080650
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855170007447Pneumograph - Non-Metallic 98in. Tubing76513NM98C76513NM98C2025-08-14
00855170007423DualGrip Digital Grip Dynamometer5030DG5030DG2024-09-11
00855170007409Lafayette Range of Motion InclinometerACU100ACU1002024-02-09
00855170007416ROMI Dual Inclinometer SystemACU100-DUALACU100-DUAL2024-02-09
0085517000738670cm Long Arm Anthropometer01290A01290A2023-06-13
0085517000739330cm Short Arm Anthropometer01291A01291A2023-06-13
00855170007140PNEUMO NONMETALIC 10' LATEX FREE76513NM10A76513NM10A2023-06-12
00855170007157PED NONMETAL PNEUMO 10' LATEX FREE76513NM10P76513NM10P2023-06-12
00855170007164NONMETAL PNEUMO 12' LUER LATEX FREE76513NM12M 76513NM12M 2023-06-12
00855170007195"PNEUMO NONMETALIC 89"" LATEX FREE"76513NM89A 76513NM89A 2023-06-12
00855170007201"PED NONMETAL PNEUMO 89"" LATEX FREE"76513NM89P 76513NM89P 2023-06-12
00855170007034Large Bone Caliper01293012932021-08-31
00855170007041Small Bone Caliper01294012942021-08-31
00855170007232Chest Depth Caliper01140 01140 2021-08-31
00855170007256Abdominal Caliper01296012962021-08-31
00855170007379Lafayette Hand-Held Dynamometer01165A01165A2022-04-28
00855170007003Lafayette Hand-Held Dynamometer01165011652021-08-31
00855170007010Lafayette Skinfold Caliper01128011282021-08-31
00855170007027Lafayette Extendable Goniometer01135011352021-08-31
00855170007119Professional Hand Evaluation Kit5030K15030K12021-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855170007447Pneumograph - Non-Metallic 98in. TubingLAFAYETTE INSTRUMENT COMPANY, INC.IXO2025-08-14
00855170007140PNEUMO NONMETALIC 10' LATEX FREELAFAYETTE INSTRUMENT COMPANY, INC.IXO2023-06-12
00855170007157PED NONMETAL PNEUMO 10' LATEX FREELAFAYETTE INSTRUMENT COMPANY, INC.IXO2023-06-12
00855170007164NONMETAL PNEUMO 12' LUER LATEX FREELAFAYETTE INSTRUMENT COMPANY, INC.IXO2023-06-12
00855170007195"PNEUMO NONMETALIC 89"" LATEX FREE"LAFAYETTE INSTRUMENT COMPANY, INC.IXO2023-06-12
00855170007201"PED NONMETAL PNEUMO 89"" LATEX FREE"LAFAYETTE INSTRUMENT COMPANY, INC.IXO2023-06-12
00855170007270Pneumograph - Non-Metallic 10ft. TubingLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00855170007287Pediatric Pneumograph - Non-Metallic w/10' TubingLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00855170007294Pneumograph - Non-Metallic 12' w/ConnectorLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00855170007300Pneumograph - Non-Metallic 14ft. TubingLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00855170007317Pneumograph - Non-Metallic 18' w/ConnectorLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00855170007324Pneumograph - Non-Metallic 89in. TubingLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00855170007348Pneumograph Nonmetalic 135cm StrapLAFAYETTE INSTRUMENT COMPANY, INC.IXO2021-08-31
00840682146395NAGE Medical Systems, L.L.C.IXO2019-09-20
00816396020788CTM-400IVY BIOMEDICAL SYSTEMS, INC.IXO2016-11-10
00816396020795CTM-400IVY BIOMEDICAL SYSTEMS, INC.IXO2016-11-10
00816396020801CTM-400IVY BIOMEDICAL SYSTEMS, INC.IXO2016-11-10
00816396022171CTM-400IVY BIOMEDICAL SYSTEMS, INC.IXO2016-11-10