FDA UDI
In Commercial Distribution
🇺🇸 United States
Fisher & Paykel Healthcare
DI: 09420012479631
·
Model: 900PT475
·
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
- 09420012479631
- Version / Model
- 900PT475
- Catalog Number
- 900PT475
- Company Name
- FISHER & PAYKEL HEALTHCARE LIMITED
- Labeler DUNS
- 590153276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-28
- Public Version
- 1
- Public Version Date
- 2024-04-05
- Public Version Status
- New
- Public Device Record Key
- dd98ded5-8543-4c4b-b02b-abd6812f1978
Device Description
Fisher & Paykel Healthcare Device Manager
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
- No
- 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 |
|---|---|---|---|---|
| 37331 | Medical equipment inventory management/maintenance software | An application software program intended to be used to manage data pertaining to the use, maintenance and servicing of medical devices and equipment, namely relating to one or more of the following: device electronic registration, inventory management, device identifiers, maintenance and servicing, spare parts ordering, equipment assessment, renewal planning or authority auditing, onboarding, firmware updating, and device diagnostic data submission to the manufacturer. It may be referred to as a medical equipment management system (MEMS) and is typically used by a clinical engineering department. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09420012479631 | GS1 |
Customer Contacts
- Phone
- 1800 446 3908
- [email protected]