FDA UDI
In Commercial Distribution
🇺🇸 United States
Emergency Medical Products
DI: 00851772007106
·
Model: E0404
·
EMERGENCY MEDICAL PRODUCTS, INC.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Emergency Medical Products
- Primary DI
- 00851772007106
- Version / Model
- E0404
- 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
- 3
- Public Version Date
- 2019-08-21
- Public Version Status
- Update
- Public Device Record Key
- f9b7fe03-ab22-412d-9d43-727e40cf10a5
Device Description
LSP Hard Case Assembly III Complete
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 |
|---|---|---|---|---|
| CAN | REGULATOR, PRESSURE, GAS CYLINDER | Anesthesiology | 868.2700 | 1 |
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
| BTL | Ventilator, emergency, powered (resuscitator) | Anesthesiology | 868.5925 | 2 |
| PHS | Oral Airway Assist | Anesthesiology | 868.5110 | 1 |
| BTA | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36690 | Cardiopulmonary resuscitation kit, reusable | A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., emergency pharmaceuticals, airway tubes, face masks or resuscitator). It is typically placed in a convenient location in public buildings and in EMS vehicles for quick access in emergency situations. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851772007106 | GS1 |