FDA UDI
In Commercial Distribution
🇺🇸 United States
LifePulse
DI: 00616120000105
·
Model: 204
·
BUNNELL, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LifePulse
- Primary DI
- 00616120000105
- Version / Model
- 204
- Company Name
- BUNNELL, INCORPORATED
- Labeler DUNS
- 023869365
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-14
- Public Version
- 4
- Public Version Date
- 2018-08-28
- Public Version Status
- Update
- Public Device Record Key
- 75b6b15a-fc44-43ff-87d0-5217959ddd42
Device Description
LifePulse High Frequency Ventilator Model 204
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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LSZ | Ventilator, High Frequency | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15783 | Stationary electric high-frequency ventilator | A mains electricity (AC-powered) automatic cycling machine intended 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. The device will typically function independently or may be used in conjunction with an intensive care ventilator to superimpose its high frequency percussive ventilation on top of a normal ventilation frequency. It is typically used in critical care situations on patients with respiratory disease requiring ventilatory assistance, typically through an artificial airway [e.g., endotracheal (ET) tube or tracheostomy]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00616120000105 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P850064 | 028 |