FDA UDI
In Commercial Distribution
🇺🇸 United States
Fisher & Paykel Healthcare
DI: 09420012436917
·
Model: OPT970
·
FISHER & PAYKEL HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Fisher & Paykel Healthcare
- Primary DI
- 09420012436917
- Version / Model
- OPT970
- Catalog Number
- OPT970
- Company Name
- FISHER & PAYKEL HEALTHCARE LIMITED
- Labeler DUNS
- 590153276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-02
- Public Version
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 2ba6a6f7-d12f-433b-9864-43055c78b93d
Device Description
Optiflow Tracheostomy Direct Connection
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Anesthesiology | 868.5450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61346 | Straight/elbow breathing circuit connector, single-use | A device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 09420012437310 | GS1 | PACK | 20 | In Commercial Distribution | |
| Primary | 09420012436917 | GS1 |
Customer Contacts
- Phone
- 1800 446 3908
- [email protected]