FDA UDI
In Commercial Distribution
🇺🇸 United States
FISHER & PAYKEL HEALTHCARE
DI: 09420012429858
·
Model: RT041L
·
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
- 09420012429858
- Version / Model
- RT041L
- Catalog Number
- 0T30
- 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
- 4
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- 589f3919-766d-4e01-9587-9880e21bdfef
Device Description
SU FACE MASK NON VENTED 10/BOX
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 |
|---|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37498 | Respiratory oxygen therapy system | An assembly of devices designed to be interconnected to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at different concentrations (e.g., via a gas mixer), duration of use, and flows. It will connect to an oxygen source and will typically include a flowmeter or flow controlling device, masks, tubing, valves, and/or nasal cannulae. It can also include, e.g., a high pressure gas reduction valve(s) and a pneumatically-powered suction device with collection bottle. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09420012429858 | GS1 | ||||
| Package | 09420012421494 | GS1 | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 1 800 446 3908
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083122 | 000 |