FDA UDI
In Commercial Distribution
🇺🇸 United States
Fisher & Paykel Healthcare
DI: 09420012412379
·
Model: BC153-10
·
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
- 09420012412379
- Version / Model
- BC153-10
- Catalog Number
- BC153-10
- Company Name
- FISHER & PAYKEL HEALTHCARE LIMITED
- Labeler DUNS
- 590153276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-10
- Public Version
- 4
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- 4fcc75cf-317a-41ad-982a-ebaeb2cf2a2c
Device Description
BC153 Bubble CPAP System
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 |
|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | 868.5905 | 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 |
|---|---|---|---|---|---|---|
| Package | 09420012414946 | GS1 | Pack | 10 | In Commercial Distribution | |
| Primary | 09420012412379 | GS1 |
Customer Contacts
- Phone
- 1800 446 3908
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100011 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius