FDA UDI
In Commercial Distribution
🇺🇸 United States
Fisher & Paykel Healthcare
DI: 09420012466662
·
Model: PT301US
·
FISHER & PAYKEL HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fisher & Paykel Healthcare
- Primary DI
- 09420012466662
- Version / Model
- PT301US
- Catalog Number
- PT301US
- Company Name
- FISHER & PAYKEL HEALTHCARE LIMITED
- Labeler DUNS
- 590153276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-05
- Public Version
- 1
- Public Version Date
- 2023-04-13
- Public Version Status
- New
- Public Device Record Key
- d71fab91-28f7-4420-97f6-cfcba5d35e25
Device Description
Respiratory Support Device
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
- 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 |
|---|---|---|---|---|
| QAV | High Flow/High Velocity Humidified Oxygen Delivery Device | Anesthesiology | 868.5454 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57828 | Professional high-flow respiratory unit, humidifying | An electrically-powered device designed to deliver high-flow (exceeding peak inspiratory flow) heated and humidified ambient air or air/oxygen to a patient in a peri-anaesthesia environment or experiencing a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), bronchiectasis, xerostomia, and mucositis]. The gases are delivered as part of noninvasive ventilation (NIV) to the patient's airway via the nose/mouth or a tracheostoma. It consists of a gas flow generator, a heating element, and humidification chamber. It is intended to be used by a healthcare provider on a spontaneously breathing patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09420012466662 | GS1 |
Customer Contacts
- Phone
- 1800 446 3908
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity