FDA.reportPublic FDA data

Emergency Medical Products

Primary DI
00851772007144
Brand
Emergency Medical Products
Company
EMERGENCY MEDICAL PRODUCTS, INC.
Model
OP-1
Device description
Ouch Pouch
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
HTDFORCEPS
LMGAgent, absorbable hemostatic, non-collagen based
MCYWound dressing kit
OVRKit, first aid, talking

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1
LMGAgent, Absorbable Hemostatic, Non-Collagen BasedGeneral, Plastic Surgery3
MCYWound Dressing KitGeneral Hospital2
OVRKit, First Aid, TalkingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851772007144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851772007144008517720071448517720071440851772007144

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, medicatedA convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436490MilleniumAvalign Technologies, Inc.HTD2026-10-08
B382SD9071922050Surgical DirectSurgical Direct, Inc.HTD2026-10-08
B382SD918660100Surgical DirectSurgical Direct, Inc.HTD2026-10-08
B382SD9013551000Surgical DirectSurgical Direct, Inc.HTD2026-10-07
B382SD9013551010Surgical DirectSurgical Direct, Inc.HTD2026-10-07
G1415140730Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G1415141510Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G141514271180Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G141549012180Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
00192896123793Adson Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123809Micro Skinner ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123823Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123830Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123847Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
G141510443190Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368200Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368300Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14151423610Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14152810910Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14154212860Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
00190776432614MillenniumAvalign Technologies, Inc.HTD2026-09-28
00190776432652MillenniumAvalign Technologies, Inc.HTD2026-09-28
00190776432683MillenniumAvalign Technologies, Inc.HTD2026-09-28
00190776432706MillenniumAvalign Technologies, Inc.HTD2026-09-28
00724995323578V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323585V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323608V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323615V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
10886982357298VOLTSynthes GmbHHTD2026-09-25
10886982357304VOLTSynthes GmbHHTD2026-09-25