FDA UDI
In Commercial Distribution
🇺🇸 United States
F&P Optiflow
DI: 09420012480347
·
Model: AA600US
·
FISHER & PAYKEL HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- F&P Optiflow
- Primary DI
- 09420012480347
- Version / Model
- AA600US
- Catalog Number
- AA600US
- Company Name
- FISHER & PAYKEL HEALTHCARE LIMITED
- Labeler DUNS
- 590153276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-29
- Public Version
- 1
- Public Version Date
- 2025-11-06
- Public Version Status
- New
- Public Device Record Key
- ac3c8e22-e995-4bc2-b363-b1af0119c610
Device Description
F&P Optiflow Air/Oxygen Flow Source
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
- Yes
- 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 |
|---|---|---|---|---|
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | Anesthesiology | 868.5330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66513 | Professional high-flow respiratory unit, non-humidifying | An electrically-powered device that is a component of a high-flow respiratory assembly designed to generate a high-flow (exceeding peak inspiratory flow) of ambient air or air/oxygen for delivery to a patient in a peri-anaesthesia environment or experiencing a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), bronchiectasis, xerostomia, and mucositis]. It is a small unit with an integrated gas flow generator; it does not include a heater or humidifier. It is intended to be used by a healthcare provider as part of noninvasive ventilation (NIV). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09420012480347 | GS1 |
Customer Contacts
- Phone
- 1808 446 3908
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243917 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity