FDA UDI
In Commercial Distribution
🇺🇸 United States
VORTRAN GO2VENT with PEEP Valve
DI: 10637320062004
·
Model: 6200
·
VORTRAN MEDICAL TECHNOLOGY 1, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- VORTRAN GO2VENT with PEEP Valve
- Primary DI
- 10637320062004
- Version / Model
- 6200
- Catalog Number
- 6200
- Company Name
- VORTRAN MEDICAL TECHNOLOGY 1, INC
- Labeler DUNS
- 090508636
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-04
- Public Version
- 1
- Public Version Date
- 2021-05-12
- Public Version Status
- New
- Public Device Record Key
- 22a62c4d-6456-40be-8f06-0fed3d5fb714
Device Description
The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, short-term, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above.
Device Characteristics
- Single Use
- Yes
- 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | Anesthesiology | 868.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57981 | Pulmonary resuscitator, pneumatic, single-use | A non-sterile device designed to provide or assist ventilation in a patient who is apnoeic or exhibits inadequate respiration through automatic pneumatic-driven pressure cycle functions. It is connected to a source of compressed oxygen (O2) and, if not entrained, medical air via oxygen/air terminal units or gas cylinder(s). It typically includes gas supply tubing, a gas control modulator, gas connector(s), safety valves, and a flex connector to connect to a face mask or endotracheal (ET) tube. It is used in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), and mass casualty incidents (MCI). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20637320062001 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 10637320062004 | GS1 |
Customer Contacts
- Phone
- (800) 434-4034
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202219 | 000 |