FDA UDI
In Commercial Distribution
🇺🇸 United States
AeroTech I Convenience Kit, Venti Pak
DI: 00879942070132
·
Model: 177-325
·
Mirion Technologies (capintec), Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AeroTech I Convenience Kit, Venti Pak
- Primary DI
- 00879942070132
- Version / Model
- 177-325
- Catalog Number
- 177-325
- Company Name
- Mirion Technologies (capintec), Inc.
- Labeler DUNS
- 047684501
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-08
- Public Version
- 2
- Public Version Date
- 2022-12-14
- Public Version Status
- Update
- Public Device Record Key
- 1cf96950-280a-4e3c-b52e-8626476a99ed
Device Description
AeroTech I Convenience Kit, Venti Pak, for Radioaerosol Administration System
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYT | System, Rebreathing, Radionuclide | Radiology | 892.1390 | 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 | 00879942070132 | GS1 |
Customer Contacts
- Phone
- 201-825-9500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K800023 | 000 |