FDA UDI
In Commercial Distribution
🇺🇸 United States
Rescuer MVP Manual Vacuum Pump
DI: B0027000MVP0
·
Model: 7000-MVP
·
B.L.S. Systems Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Rescuer MVP Manual Vacuum Pump
- Primary DI
- B0027000MVP0
- Version / Model
- 7000-MVP
- Catalog Number
- 7000-MVP
- Company Name
- B.L.S. Systems Limited
- Labeler DUNS
- 200103823
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-02
- Public Version
- 2
- Public Version Date
- 2023-06-08
- Public Version Status
- Update
- Public Device Record Key
- 61a1d355-3a39-4c40-9ac4-269b63d4f98f
Device Description
Rescuer MVP Manual Vacuum Pump with Collection jar and two oral suction catheters
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | General, Plastic Surgery | 878.4680 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63644 | Emergency airway clearance suction pump, manual | A manually-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure for emergency aspiration of fluids, secretions, or other unwanted materials from the airway of a patient. It is typically used during patient transport or for emergency situations (e.g., placed on a crash cart); it is not intended for surgical use. It may include collection containers, microbial filter, valve, or tubing; it does not include patient contact devices (e.g., tips, catheters). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B0027000MVP4 | HIBCC | Case | 20 | In Commercial Distribution | |
| Primary | B0027000MVP0 | HIBCC |
Customer Contacts
- Phone
- 9053391069
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius