FDA.reportPublic FDA data

Emergency Medical Products

Primary DI
00851772007106
Brand
Emergency Medical Products
Company
EMERGENCY MEDICAL PRODUCTS, INC.
Model
E0404
Device description
LSP Hard Case Assembly III Complete
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
BTAPUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
BTLVentilator, emergency, powered (resuscitator)
CANREGULATOR, PRESSURE, GAS CYLINDER
GCJLaparoscope, general & plastic surgery
PHSOral Airway Assist

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2
CANRegulator, Pressure, Gas CylinderAnesthesiology1
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
PHSOral Airway AssistAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851772007106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851772007106008517720071068517720071060851772007106

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation kit, reusableA collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., emergency pharmaceuticals, airway tubes, face masks or resuscitator). It is typically placed in a convenient location in public buildings and in EMS vehicles for quick access in emergency situations. This is a reusable 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
00851772007113Emergency Medical ProductsE05042016-09-24
00851772007168Emergency Medical ProductsEMPX2016-09-24
00851772007175Emergency Medical ProductsEMPXT2016-09-24
00851772007281Emergency Medical ProductsEMPX-C2016-09-24
00851772007069Emergency Medical ProductsIFAK2-B2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD4162910Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD55670280Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31
B382SD13768130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD13798130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD14678780Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15378970Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15458990Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD161090Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD169920Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD30109760Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093838ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-07-29
00198506092435ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28