FDA UDI
In Commercial Distribution
🇺🇸 United States
Emergency Medical Products
DI: 00851772007151
·
Model: WI-FR
·
EMERGENCY MEDICAL PRODUCTS, INC.
Product Codes
12
GMDN Terms
5
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Emergency Medical Products
- Primary DI
- 00851772007151
- Version / Model
- WI-FR
- 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
- 5
- Public Version Date
- 2024-11-25
- Public Version Status
- Update
- Public Device Record Key
- 12ec99df-5371-488a-bddc-3a1fc26763da
Device Description
Wisconsin First Responder Pediatric Kit
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 |
|---|---|---|---|---|
| BYG | MASK, OXYGEN | Anesthesiology | 868.5580 | 1 |
| CAN | REGULATOR, PRESSURE, GAS CYLINDER | Anesthesiology | 868.2700 | 1 |
| HTD | FORCEPS | General, Plastic Surgery | 878.4800 | 1 |
| GAX | TOURNIQUET, NONPNEUMATIC | General, Plastic Surgery | 878.5900 | 1 |
| FMC | Patient examination glove | General Hospital | 880.6250 | 1 |
| LDE | STETHOSCOPE, MANUAL | Cardiovascular | 870.1875 | 1 |
| MCY | Wound dressing kit | General Hospital | 880.5075 | 2 |
| PHS | Oral Airway Assist | Anesthesiology | 868.5110 | 1 |
| DXQ | blood pressure cuff | Cardiovascular | 870.1120 | 2 |
| BTM | Ventilator, emergency, manual (resuscitator) | Anesthesiology | 868.5915 | 2 |
| IMD | PACK, HOT OR COLD, DISPOSABLE | Physical Medicine | 890.5710 | 1 |
| NOC | Splint, extremity, non-inflatable, external, non-sterile | General, Plastic Surgery | 878.3910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13755 | Mechanical external stethoscope | A non-powered, external listening device designed to be placed on the patient’s skin to listen sounds from the arms, heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the user’s ears. This is a reusable device. | No | Active |
| 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 |
| 36290 | Suction oesophageal intubation detector, adult | A device designed to verify endotracheal (ET) tube placement by the application of a partial vacuum (using a plunger syringe or a self-inflating bulb) through a small calibre tube introduced into the tracheal tube during airway management. It is used during adult intubation. This device exploits the anatomic difference between the trachea and the oesophagus: when the detector bulb or syringe is depressed (a partial vacuum is applied) it refills with air if the intubation is tracheal, and fails to fill if the intubation is oesophageal (the oesophagus collapses around the tube). It is used in healthcare facilities or in the field to evaluate oesophageal intubation. This is a single-use device. | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851772007151 | GS1 |