FDA UDI
In Commercial Distribution
🇺🇸 United States
Optiflow
DI: 09420012480767
·
Model: AA511
·
FISHER & PAYKEL HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Optiflow
- Primary DI
- 09420012480767
- Version / Model
- AA511
- Catalog Number
- AA511
- Company Name
- FISHER & PAYKEL HEALTHCARE LIMITED
- Labeler DUNS
- 590153276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-06
- Public Version
- 1
- Public Version Date
- 2025-10-14
- Public Version Status
- New
- Public Device Record Key
- 49f6c988-3632-41d6-872f-79ce73a8680c
Device Description
GCX Dovetail Mounting Adapter
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
- Yes
- 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 |
|---|---|---|---|---|
| FOX | Stand, Infusion | General Hospital | 880.6990 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41893 | Medical device service rail clamp | A clamp designed to fit onto a medical device mounting rail or medical device service rail system to provide a secure method of fixing/mounting (holding) other medical or non-medical devices being used in the vicinity for patient treatment/care. It will typically be used in a hospital ward, a treatment room or an intensive care unit (ICU). It will have a gripping profile that is compatible to the medical rail it is intended to fit and a locking mechanism providing extra safety against inadvertent loosening. To this clamp, other adaptors may be fitted/slotted to provide holders for the devices to be carried, or it may have a dedicated function for which it is solely designed. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09420012480767 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius