FDA UDI
In Commercial Distribution
🇺🇸 United States
Percussionaire
DI: 00849436000235
·
Model: F00038-2
·
PERCUSSIONAIRE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Percussionaire
- Primary DI
- 00849436000235
- Version / Model
- F00038-2
- Catalog Number
- S00033-2
- Company Name
- PERCUSSIONAIRE CORPORATION
- Labeler DUNS
- 603048778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f661791c-bf04-46f4-b3c2-a6cd58faf947
Device Description
Sinusoidal Bronchotron and Universal Monitron Transport.
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 |
|---|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59944 | Transport pneumatic high-frequency ventilator | A pneumatically-powered automatic cycling machine intended to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is used to assist or control alveolar ventilation using a frequency that is considerably higher than the physiological breathing rate and a tidal volume less than or equal to the anatomic dead space (percussive ventilation). It is typically a compact, lightweight, rugged device powered either by institutional gas supply or on-board compressor systems, with manually-operated user interface. It is used in conjunction with an endotracheal (ET) tube, tracheostomy cannula, or mask. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849436000235 | GS1 |
Customer Contacts
- Phone
- 208-263-2549
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905235 | 000 |