FDA UDI
In Commercial Distribution
🇺🇸 United States
Fisher & Paykel Healthcare
DI: 09420012466679
·
Model: PT311US
·
FISHER & PAYKEL HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Fisher & Paykel Healthcare
- Primary DI
- 09420012466679
- Version / Model
- PT311US
- Catalog Number
- PT311US
- Company Name
- FISHER & PAYKEL HEALTHCARE LIMITED
- Labeler DUNS
- 590153276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-11
- Public Version
- 1
- Public Version Date
- 2024-09-19
- Public Version Status
- New
- Public Device Record Key
- ae56fd95-1c8b-4eec-83a2-8c14520826c2
Device Description
Airvo 3 NIV 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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| MNT | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65491 | Professional BPAP/high-flow respiratory unit | An electrically-powered device designed to deliver heated and humidified ambient air or air/oxygen to a patient during both: 1) high-flow (exceeding peak inspiratory flow) respiratory therapy; and 2) bi-level positive airway pressure (BPAP). It consists of a gas flow generator that entrains room air, an oxygen input, a heating element, humidification chamber, and both pressure and flow sensors. It is intended for use 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 | 09420012466679 | GS1 |
Customer Contacts
- Phone
- 1800 446 3908
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233643 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity