FDA UDI
In Commercial Distribution
🇺🇸 United States
Emergency Medical Products
DI: 00851772007175
·
Model: EMPXT
·
EMERGENCY MEDICAL PRODUCTS, INC.
Product Codes
3
GMDN Terms
4
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Emergency Medical Products
- Primary DI
- 00851772007175
- Version / Model
- EMPXT
- 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
- 2024-04-03
- Public Version Status
- Update
- Public Device Record Key
- 03d9b331-a0b9-4c86-b103-7d2ea15d3946
Device Description
X Pouch - Tactical Black
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| OVR | Kit, first aid, talking | General, Plastic Surgery | 878.4014 | 1 |
| LMG | Agent, absorbable hemostatic, non-collagen based | General, Plastic Surgery | 878.4490 | 3 |
| OPA | Powder-free non-natural rubber latex surgeon's gloves |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16156 | Aneroid manual sphygmomanometer | A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may be mounted to a wall, placed on a table, or hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope. | No | Active |
| 36690 | Cardiopulmonary resuscitation kit, reusable | A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a reusable device. | No | Active |
| 44039 | First aid kit, medicated | A 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. | No | Active |
| 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851772007175 | GS1 |