FDA.reportPublic FDA data

Emergency Medical Products

Primary DI
00851772007069
Brand
Emergency Medical Products
Company
EMERGENCY MEDICAL PRODUCTS, INC.
Model
IFAK2-B
Device description
IFAK Officer Down Kit w/Back 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
LMGAgent, absorbable hemostatic, non-collagen based
OJSTourniquet kit
OPAPowder-free non-natural rubber latex surgeon's gloves
OVRKit, first aid, talking

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMGAgent, Absorbable Hemostatic, Non-Collagen BasedGeneral, Plastic Surgery3
OJSTourniquet KitGeneral, Plastic Surgery1
OPAPowder-free non-natural rubber latex surgeon's gloves
OVRKit, First Aid, TalkingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851772007069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851772007069008517720070698517720070690851772007069

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, non-bioabsorbable, antimicrobialA non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC)] that contains an antimicrobial agent to help prevent infection, intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis. It is available in various forms (e.g., gel, spray, ointment) that can be applied directly to the wound where it forms a seal until removed. It is typically available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810132043956HCSConcordance Healthcare Solutions LLCOVR2025-03-04
06975033060069WAPShenzhen WAP-health Technology Co.LtdOVR2024-07-12
00860010506905CoreglovesSMARTLOGICS LLCOPA2023-09-06
00860010506912CoreglovesSMARTLOGICS LLCOPA2023-09-06
00860010506929CoreglovesSMARTLOGICS LLCOPA2023-09-06
00860010506936CoreglovesSMARTLOGICS LLCOPA2023-09-06
00860010506943CoreglovesSMARTLOGICS LLCOPA2023-09-06
00860010506950CoreglovesSMARTLOGICS LLCOPA2023-09-06
00860010506967CoreglovesSMARTLOGICS LLCOPA2023-09-06
00860010506974CoreglovesSMARTLOGICS LLCOPA2023-09-06
00860010506981CoreglovesSMARTLOGICS LLCOPA2023-09-06
00860010506998CoreglovesSMARTLOGICS LLCOPA2023-09-06
10705031468085SURGICEL NU-KNITEthicon SàrlLMG2023-07-28
30705031468089SURGICEL NU-KNITEthicon SàrlLMG2023-07-28
05413765891380PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
05413765891335PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
05413765891366PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
05413765891373PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
75413765891389PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
05413765891397PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
10705031468092SURGICEL NU-KNITEthicon SàrlLMG2023-05-15
10705031468108SURGICELEthicon SàrlLMG2023-05-15
10705031468115SURGICELEthicon SàrlLMG2023-05-15
10705031468122SURGICELEthicon SàrlLMG2023-05-15
10705031468139SURGICELEthicon SàrlLMG2023-05-15
30705031468096SURGICEL NU-KNITEthicon SàrlLMG2023-05-15
30705031468102SURGICELEthicon SàrlLMG2023-05-15
30705031468119SURGICELEthicon SàrlLMG2023-05-15
30705031468126SURGICELEthicon SàrlLMG2023-05-15
30705031468133SURGICELEthicon SàrlLMG2023-05-15