FDA UDI
In Commercial Distribution
🇺🇸 United States
F&P OptiPAP Junior
DI: 09420012479105
·
Model: OPTIPAPC1724
·
FISHER & PAYKEL HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- F&P OptiPAP Junior
- Primary DI
- 09420012479105
- Version / Model
- OPTIPAPC1724
- Catalog Number
- OPTIPAPC1724
- Company Name
- FISHER & PAYKEL HEALTHCARE LIMITED
- Labeler DUNS
- 590153276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-23
- Public Version
- 1
- Public Version Date
- 2026-02-02
- Public Version Status
- New
- Public Device Record Key
- 29bb6a00-c8c1-42a0-8eaa-1802fba0336e
Device Description
OptiPAP Junior Chinstrap 17-24cm
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
- Yes
- 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 |
|---|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | Anesthesiology | 868.5975 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65873 | CPAP/BPAP chin strap, single-use | A non-latex device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) therapy using a nasal mask or cannula, to control mouth air leaks by gently holding the mouth closed. It is available in sizes appropriate for neonatal/infant to adult patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 09420012479112 | GS1 | PACK | 10 | In Commercial Distribution | |
| Primary | 09420012479105 | GS1 |
Customer Contacts
- Phone
- 1803 446 3908
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 17-24CM |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 122 Degrees Fahrenheit