Pneumo Nonmetalic 89" Latex Free

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 76513NM89A

by Lafayette Instrument Company

Identity

Trade Name: PNEUMO NONMETALIC 89" LATEX FREE EUDAMEDFDA UDI
Generic Name: MRI system synchronizer FDA UDI
Device Name: Latex-Free Non- Metallic Pneumograph EUDAMED
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. FDA UDI
Model / Reference: 76513NM89A EUDAMEDFDA UDI
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. FDA UDI

Identifiers

Catalog Number: 76513NM89A FDA UDI
Primary DI / UDI-DI: 00855170007195 EUDAMEDFDA UDI
Basic UDI-DI: 0855170007NMPNEUMOGRAPHU9 EUDAMED
FDA Product Code: IXO FDA UDI
EMDN Code: Z1105018099 MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER EUDAMED
GMDN Term: MRI system synchronizer FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 892.1970 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Pneumo Nonmetalic 89" Latex Free by Lafayette Instrument Company — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	0855170007NMPNEUMOGRAPHU9	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Lafayette Instrument Company
EUDAMED SRN: US-MF-000041816
Authorised Representative: AJW Technology Consulting GmbH DE-AR-000004999

Sources (2)

EUDAMED 9d972eb6-1e39-4c30-ac1b-4111387509a7 61 fields · synced Jul 14, 2026
FDA UDI f19f4512-b559-477f-905e-b6eb133ac12c 36 fields · synced May 29, 2026