FDA UDI
In Commercial Distribution
🇺🇸 United States
LifeVac School KIT
DI: B712LVC3003
·
Model: LVC3003
·
LIFEVAC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LifeVac School KIT
- Primary DI
- B712LVC3003
- Version / Model
- LVC3003
- Company Name
- LIFEVAC, INC.
- Labeler DUNS
- 071298464
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-25
- Public Version
- 2
- Public Version Date
- 2024-03-20
- Public Version Status
- Update
- Public Device Record Key
- a5a5a2a3-d9b9-41b4-be58-925ff8d9e9d0
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63287 | Emergency airway clearance suction plunger | A noninvasive, manual device designed for the emergency removal of an airway-obstructing object or material in the oropharynx, trachea, or bronchi to prevent patient asphyxiation. It is in the form of a compression tank (plunger) connected to a face-fitting mask that is applied to the mouth area; the plunger is manually compressed and expanded to provide a negative pressure within the airway to suck out the obstructing material. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B712LVC3003 | HIBCC |
Customer Contacts
- Phone
- +1-516-965-1900
- [email protected]