FDA UDI
In Commercial Distribution
🇺🇸 United States
Emergency Medical Products
DI: 00851772007052
·
Model: IFAK-O
·
EMERGENCY MEDICAL PRODUCTS, INC.
Product Codes
6
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Emergency Medical Products
- Primary DI
- 00851772007052
- Version / Model
- IFAK-O
- 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
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- aa0974c2-4239-4e3d-ade8-64db042c0d7f
Device Description
IFAK Officer Down Kit - Orange Pouch - Basic
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 |
|---|---|---|---|---|
| OPA | Powder-free non-natural rubber latex surgeon's gloves | |||
| OVR | Kit, first aid, talking | General, Plastic Surgery | 878.4014 | 1 |
| LDE | STETHOSCOPE, MANUAL | Cardiovascular | 870.1875 | 1 |
| IMD | PACK, HOT OR COLD, DISPOSABLE | Physical Medicine | 890.5710 | 1 |
| DXQ | blood pressure cuff | Cardiovascular | 870.1120 | 2 |
| MCY | Wound dressing kit | General Hospital | 880.5075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 |
| 13755 | Mechanical stethoscope | A mechanical listening device designed for listening to sounds from the 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 users ears. Mechanical stethoscopes are typically found in two variants 1) a general-purpose stethoscope used for clinical/ward activities; or 2) a reinforced stethoscope used by cardiologists. | No | Active |
| 37326 | Blood pressure cuff, single-use | A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851772007052 | GS1 |