FDA.reportPublic FDA data

AeroPace Airway Sensor

Primary DI
00810073210080
Brand
AeroPace Airway Sensor
Company
Lungpacer Medical USA Inc.
Model
000-0041
Published
2025-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
SDLTransvenous Temporary Phrenic Nerve Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDLTransvenous Temporary Phrenic Nerve StimulatorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240012000AeroPace® SystemLungpacer Medical USA, Inc.2024-12-04SDL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810073210080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810073210080008100732100808100732100800810073210080

GMDN Terms#

Term, Definition table
TermDefinition
Transvenous phrenic nerve electrical stimulation control unitAn electrically-powered device designed to configure/deliver stimulation of the phrenic nerve, via a transvenous electrode, to cause contraction of the diaphragm in conjunction with mechanical ventilation to assist earlier ventilation weaning. It consists of a pulse generator and a graphical user interface to adjust settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080998049
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810073210004AeroPace Neurostimulation Catheter Kit000-00362025-03-10
00810073210028AeroPace Catheter Cable000-00432025-03-10
00810073210035AeroPace Airway Sensor Cable000-00452025-03-10
00810073210042AeroPace Handheld Controller000-00392025-03-10
00810073210103AeroPace Neurostimulation Console Cart000-00572025-03-10
00810073210127AeroPace Neurostimulation Console000-00552025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810073210028AeroPace Catheter CableLungpacer Medical USA Inc.SDL2025-03-10
00810073210035AeroPace Airway Sensor CableLungpacer Medical USA Inc.SDL2025-03-10
00810073210042AeroPace Handheld ControllerLungpacer Medical USA Inc.SDL2025-03-10
00810073210103AeroPace Neurostimulation Console CartLungpacer Medical USA Inc.SDL2025-03-10
00810073210127AeroPace Neurostimulation ConsoleLungpacer Medical USA Inc.SDL2025-03-10