FDA UDI
In Commercial Distribution
🇺🇸 United States
CURAPLEX
DI: 00612223310271
·
Model: 301-P3100H-L
·
PEGASUS RESEARCH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CURAPLEX
- Primary DI
- 00612223310271
- Version / Model
- 301-P3100H-L
- Catalog Number
- P3100HC-L
- Company Name
- PEGASUS RESEARCH CORPORATION
- Labeler DUNS
- 185432994
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 18c09881-0452-4fa2-8e20-f411cd9c6037
Device Description
CLOSED DILUTION NEBULIZER, HIGH FLOW, UP TO 40 LPM, LONG TUBE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | 868.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61167 | Nebulizing adaptor | A non-powered small connecting device, which includes an integrated nebulizer, intended to join a sterile water or sterile isotonic sodium chloride solution reservoir to a respiratory gas source (typically wall outlet) and a gas administration device (e.g., mask, mouthpiece). It is designed to generate aerosolized fluid (finely dispersed airborne droplets in a liquid phase) to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 612223310226 | GS1 | CA | 40 | In Commercial Distribution | |
| Primary | 00612223310271 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K962534 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 16 | Inch | |
| Outer Diameter | 2.5 | Inch | |
| Height | 3.5 | Inch |