Emergency Medical Products

Basic Information

• Brand Name: Emergency Medical Products
• Primary DI: 00851772007069
• Version / Model: IFAK2-B
• Company Name: EMERGENCY MEDICAL PRODUCTS, INC.
• Labeler DUNS: 061738290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 12d69040-342b-479e-9950-84cd93afb933

Device Description

IFAK Officer Down Kit w/Back Pouch

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LMG	Agent, absorbable hemostatic, non-collagen based	General, Plastic Surgery	878.4490	3
OJS	Tourniquet kit	General, Plastic Surgery	878.5900	1
OVR	Kit, first aid, talking	General, Plastic Surgery	878.4014	1
OPA	Powder-free non-natural rubber latex surgeon's gloves

GMDN Terms

Code	Name	Definition	Implantable	Status
58058	Plant polysaccharide haemostatic agent, non-bioabsorbable, antimicrobial	A 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 intended for use in the home or healthcare facility. This is a single-use device.	No	Active
35844	Limb tourniquet, manual, reusable	A strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It will typically have a fastening mechanism (e.g., Velcro or a self-locking buckle) that allows adjustments to the degree of tightness. This is a reusable device which may be intended for single- or multi-patient use.	No	Active
34864	Adhesive bandage	A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851772007069	GS1