FDA UDI
In Commercial Distribution
🇺🇸 United States
Aerotech I Radioaerosol Administration System
DI: 00718175003244
·
Model: 177-324
·
BIODEX MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Aerotech I Radioaerosol Administration System
- Primary DI
- 00718175003244
- Version / Model
- 177-324
- Catalog Number
- 177-324
- Company Name
- BIODEX MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 043833813
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-18
- Public Version
- 4
- Public Version Date
- 2018-09-06
- Public Version Status
- Update
- Public Device Record Key
- 44b0bf87-9d2f-4ac7-b307-15461970be51
Device Description
AeroTech I Convenience Kit with small particle delivery system
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| 16784 | Radioaerosol administration set | A collection of devices used to quickly deliver radioaerosol to a patient for ventilatory pulmonary scintigraphy. It is used with an aerosol pump/nebulizer or a compressed air line to generate the radioactive aerosol, and a lead (Pb) protective container to hold the radioactive solution during the inhalation procedure. It typically consists of one or several one-way valves to direct the flow of aerosol to the patient, transport tubing to carry the aerosol to the patient, a mouthpiece, and a bacteria filter to trap any exhaled aerosol. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00718175003244 | GS1 | ||||
| Package | 20718175003262 | GS1 | Box | 10 | In Commercial Distribution | |
| Package | 10718175003258 | GS1 | Box | 5 | In Commercial Distribution | |
| Package | 30718175003276 | GS1 | Box | 25 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K800023 | 000 |