FDA UDI
In Commercial Distribution
🇺🇸 United States
Aero/Vent Plus, Aero/Vent Max, Aero/Vent Jr.
DI: 00857863007376
·
Model: UV-204-SA
·
Medi/Nuclear Corporation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aero/Vent Plus, Aero/Vent Max, Aero/Vent Jr.
- Primary DI
- 00857863007376
- Version / Model
- UV-204-SA
- Company Name
- Medi/Nuclear Corporation, Inc.
- Labeler DUNS
- 079628327
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-09
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 76b21864-3314-4505-a42a-ee45bb7b3f0f
Device Description
Mobile Cabinet w/Swing Arm (for Aero/Vent Jr., Aero/Vent Max, and Aero/Vent Plus Lead Shields) - Metal. Powder coated steel, almond color cabinet includes locking decay leaded area, storage area for supplies, swivel casters with front brakes, rubber bumpers on all corners and a rotating swing arm that locks the shield in place and brings it close to a patient. Oxygen tank holder is optional.
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| IYT | System, Rebreathing, Radionuclide | Radiology | 892.1390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40684 | Teletherapy radionuclide system table, non-powered | A device that is a component of a teletherapy radionuclide system (commonly known as a cobalt therapy machine) and that is a non-electrical radiotherapy table specifically designed to position and support a patient during therapeutic radiation treatments administered using a radionuclide teletherapy system (e.g., a Cobalt-60 teletherapy system). It has a fixed position table top or mechanical table top positioning and/or table height controls, e.g., pneumatic controls, magnetic locks, cranks and lever mechanisms. It can be a stationary or mobile unit, or incorporated as an integral component of a radionuclide teletherapy system or gantry configuration. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857863007376 | GS1 |
Customer Contacts
- Phone
- 800-321-5981
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K865107 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 110 | Pound | |
| Height | 26 | Inch | |
| Depth | 14 | Inch | |
| Width | 19.5 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- store at room temperature