FDA UDI
In Commercial Distribution
🇺🇸 United States
AV-S MRI Ventilator
DI: 05051977000567
·
Model: AV-S MRI
·
PENLON LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AV-S MRI Ventilator
- Primary DI
- 05051977000567
- Version / Model
- AV-S MRI
- Company Name
- PENLON LTD
- Labeler DUNS
- 458942687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 81b6964f-5d85-4b94-93fe-9bf3135279a4
Device Description
AV-S Ventilator for use in an MRI environment
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
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34851 | Anaesthesia ventilator | A mains electricity (AC-powered) stand-alone, automatic cycling device used to assist and control alveolar ventilation during general anaesthesia, and is compatible with inhaled anaesthetic agents. It has fewer functions and is less complex to operate than an intensive care ventilator, but adequately meets the patient's ventilation needs for oxygen (O2) and carbon dioxide (CO2) exchange to maintain normal blood gas concentrations. The device provides a mechanical means to deliver the breathing gas to the patient in a controlled pattern, and is equipped with alarms to warn of changes in respiration or the onset of unsafe operating conditions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051977000567 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051222 | 000 |