FDA UDI
In Commercial Distribution
🇺🇸 United States
DART
DI: 00841470100285
·
Model: DART300
·
PULMODYNE INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DART
- Primary DI
- 00841470100285
- Version / Model
- DART300
- Company Name
- PULMODYNE INC
- Labeler DUNS
- 030619483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-25
- Public Version
- 1
- Public Version Date
- 2022-04-04
- Public Version Status
- New
- Public Device Record Key
- e9968bf5-81d7-424a-be44-32bcaa43abd6
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
- No
- 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 |
|---|---|---|---|---|
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Anesthesiology | 868.5640 | 1 |
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 |
|---|---|---|---|---|---|---|
| Package | 10841470100282 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00841470100285 | GS1 |