FDA.reportPublic FDA data

Emergency Medical Products

Primary DI
00851772007083
Brand
Emergency Medical Products
Company
EMERGENCY MEDICAL PRODUCTS, INC.
Model
EMP4000RC
Device description
LA Rescue ALS Airway Kit - Red
Published
2016-09-24
Public version status
Update
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
BTRTube, tracheal (w/wo connector)
FMFSyringe, piston
HTDFORCEPS
OGHLaryngoscope kit
PHSOral Airway Assist

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2
FMFSyringe, PistonGeneral Hospital2
HTDForcepsGeneral, Plastic Surgery1
OGHLaryngoscope KitAnesthesiology1
PHSOral Airway AssistAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851772007083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851772007083008517720070838517720070830851772007083

GMDN Terms#

Term, Definition table
TermDefinition
Suction oesophageal intubation detector, adultA device designed to verify endotracheal (ET) tube placement by the application of a partial vacuum (using a plunger syringe or a self-inflating bulb) through a small calibre tube introduced into the tracheal tube during airway management. It is used during adult intubation. This device exploits the anatomic difference between the trachea and the oesophagus: when the detector bulb or syringe is depressed (a partial vacuum is applied) it refills with air if the intubation is tracheal, and fails to fill if the intubation is oesophageal (the oesophagus collapses around the tube). It is used in healthcare facilities or in the field to evaluate oesophageal intubation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
061738290
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851772007038Emergency Medical ProductsLA8641-C2016-09-24
00851772007045Emergency Medical ProductsIFAK-B2016-09-24
00851772007052Emergency Medical ProductsIFAK-O2016-09-24
00851772007120Emergency Medical ProductsEMP3250GC2016-09-24
00851772007137Emergency Medical ProductsEMP3250GCO2017-12-22
00851772007151Emergency Medical ProductsWI-FR2016-09-24
00851772007182Emergency Medical ProductsLA8641B2016-09-24
00851772007199Emergency Medical ProductsLA8641N2016-09-24
00851772007205Emergency Medical ProductsLA8641R2016-09-24
00851772007212Emergency Medical ProductsEMP3250RCO2016-09-24
00851772007229Emergency Medical ProductsEMP3250NCO2016-09-24
00851772007236Emergency Medical ProductsEMP3250RC2016-09-24
00851772007243Emergency Medical ProductsEMP3250NC2016-09-24
00851772007298Emergency Medical ProductsEMP3250GC-C2016-09-27
00851772007304Emergency Medical ProductsEMP3250GCO-C2016-09-27
00851772007106Emergency Medical ProductsE04042016-09-24
00851772007113Emergency Medical ProductsE05042016-09-24
00851772007168Emergency Medical ProductsEMPX2016-09-24
00851772007175Emergency Medical ProductsEMPXT2016-09-24
00851772007281Emergency Medical ProductsEMPX-C2016-09-24

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Primary DI, Brand, Company table
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