FDA UDI
In Commercial Distribution
🇺🇸 United States
Neb.Plus
DI: 04710810100550
·
Model: NV33
·
GALEMED CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Neb.Plus
- Primary DI
- 04710810100550
- Version / Model
- NV33
- Catalog Number
- RF1 Nebulizer w/Neb-1.T Valve Kit, 22M, 22M
- Company Name
- GALEMED CORPORATION
- Labeler DUNS
- 656854379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-15
- Public Version
- 3
- Public Version Date
- 2024-10-24
- Public Version Status
- Update
- Public Device Record Key
- 8469b305-d2f4-4d7b-be51-c25fa2c68c19
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| BZA | Connector, Airway (Extension) | Anesthesiology | 868.5810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42421 | Nasopharyngeal airway, reusable | A rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. The proximal end of the device may have an integral 22 mm connector for oxygen delivery. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 44710810100558 | GS1 | Carton | 25 | In Commercial Distribution | |
| Primary | 04710810100550 | GS1 |