FDA UDI
In Commercial Distribution
🇺🇸 United States
NEBULIZER PACIFIER W/ELBOW CONNECTOR & NEBULIZER BOTTLE 6cc&7Ft TUBING
DI: 04716770315812
·
Model: NB-31581
·
BESMED HEALTH BUSINESS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NEBULIZER PACIFIER W/ELBOW CONNECTOR & NEBULIZER BOTTLE 6cc&7Ft TUBING
- Primary DI
- 04716770315812
- Version / Model
- NB-31581
- Company Name
- BESMED HEALTH BUSINESS CORP.
- Labeler DUNS
- 658023775
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-14
- Public Version
- 4
- Public Version Date
- 2021-06-08
- Public Version Status
- Update
- Public Device Record Key
- d9c32bfa-e769-4df5-adbd-14f2d93f87f4
Device Description
NEBULIZER PACIFIER W/ELBOW CONNECTOR & NEBULIZER BOTTLE 6cc&7Ft TUBING
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
- 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 |
|---|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | 868.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10226 | Atomizer, non-ventilatory | A non-powered, non-ventilatory device intended to provide liquid medication in an aerosolized airborne form for a patient to breathe. It is typically hand-operated. Unlike a nebulizer this devices lacks a baffle, therefore the particle size of the aerosol is not stabilized. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04716770315812 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091272 | 000 |