FDA UDI
In Commercial Distribution
🇺🇸 United States
VOCSN Travel Suction Canister
DI: 00855573007129
·
Model: PRT-00824-000
·
VENTEC LIFE SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VOCSN Travel Suction Canister
- Primary DI
- 00855573007129
- Version / Model
- PRT-00824-000
- Catalog Number
- PRT-00824-001
- Company Name
- VENTEC LIFE SYSTEMS, INC.
- Labeler DUNS
- 078758082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-11
- Public Version
- 6
- Public Version Date
- 2019-01-31
- Public Version Status
- Update
- Public Device Record Key
- 58955e25-b212-40e9-8bf2-79c91ac9ab88
Device Description
VOCSN Travel Suction Canister
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47366 | Emergency airway clearance suction system, electric | A portable assembly of devices, which includes a non-surgical invasive component, intended to aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes an electrically-powered suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00855573007143 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00855573007129 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162877 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 300 | Milliliter |