FDA UDI
In Commercial Distribution
🇺🇸 United States
FISHER & PAYKEL HEALTHCARE
DI: 09420012429810
·
Model: RT008
·
FISHER & PAYKEL HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- FISHER & PAYKEL HEALTHCARE
- Primary DI
- 09420012429810
- Version / Model
- RT008
- Catalog Number
- RT008
- Company Name
- FISHER & PAYKEL HEALTHCARE LIMITED
- Labeler DUNS
- 590153276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-25
- Public Version
- 6
- Public Version Date
- 2026-04-15
- Public Version Status
- Update
- Public Device Record Key
- bdf3d20d-9f02-4158-aaaa-3260b32a7bba
Device Description
Air entrainer
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
- Yes
- 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 |
|---|---|---|---|---|
| 44225 | Oxygen/air breathing gas mixer, hospital | An independent mechanical device designed for accurate mixing of air and oxygen (O2) with O2 concentrations ranging from 21% to 100% (oxygen/air proportioner) that are appropriated for breathing in patients who need a concentration of O2 above the normal concentration in air. The mixer receives air and oxygen from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. The mixer may deliver the gas to the patient through devices such as ventilators, tracheostomy tubes, endotracheal (ET) tubes, oxygen tents, and/or masks. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09420012429810 | GS1 | ||||
| Package | 09420012403315 | GS1 | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 1 800 446 3908
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K953711 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius