FDA UDI
In Commercial Distribution
🇺🇸 United States
Percussionaire
DI: 00849436000563
·
Model: F00001-C
·
PERCUSSIONAIRE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Percussionaire
- Primary DI
- 00849436000563
- Version / Model
- F00001-C
- Catalog Number
- S00002-C-EU
- Company Name
- PERCUSSIONAIRE CORPORATION
- Labeler DUNS
- 603048778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-03
- Public Version
- 1
- Public Version Date
- 2019-01-03
- Public Version Status
- New
- Public Device Record Key
- f47a1a8c-7e5d-4e39-a300-5916715b62d9
Device Description
IPV1C, English, European Multimeter, DISS Gas Outlet
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| NHJ | Device, Positive Pressure Breathing, Intermittent | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59943 | Portable pneumatic high-frequency ventilator | A pneumatically-powered device designed to be easily moved/mounted and intended to provide long-term support or therapeutic alveolar ventilation for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs using a frequency that is considerably higher than physiological breathing rates and a tidal volume less than or equal to the anatomic dead space (percussive ventilation), typically through an endotracheal (ET) tube, tracheostomy cannula, or mask. It typically includes a control system and alarms, sometimes with additional features (e.g., humidification). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10849436000560 | GS1 | Case | 1 | In Commercial Distribution | |
| Primary | 00849436000563 | GS1 |
Customer Contacts
- Phone
- 208-263-2549
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905236 | 000 |