FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoPAP Cannula - XS
DI: B0361078611
·
Model: 1078611
·
CIRCADIANCE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NeoPAP Cannula - XS
- Primary DI
- B0361078611
- Version / Model
- 1078611
- Catalog Number
- 1078611
- Company Name
- CIRCADIANCE, LLC
- Labeler DUNS
- 012721295
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-29
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 042cca23-3b12-4c03-ad72-10b4890b1d99
Device Description
NeoPAP Cannula - XS
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
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 61197 | Neonatal CPAP unit | A mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) of a neonatal/infant patient via an attached nasal cannula or mask, using continuous positive airway pressure (CPAP) during spontaneous respiration. It is an electronic unit with controls, and may be used with compressed medical gas cylinders [e.g., air, oxygen (O2)] or include an O2 concentrator compartment; additional features (e.g., adjustable flow rates and O2 concentration, humidification) may be provided. It is primarily intended for use in a healthcare facility, especially in intensive and critical care settings. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B0361074119 | HIBCC | Single | 10 | In Commercial Distribution | |
| Primary | B0361078611 | HIBCC |
Customer Contacts
- Phone
- 1-888-825-9640
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103410 | 000 |