FDA UDI
In Commercial Distribution
🇺🇸 United States
Aero/Vent Plus
DI: 00857863007918
·
Model: AV-1010
·
Medi/Nuclear Corporation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aero/Vent Plus
- Primary DI
- 00857863007918
- Version / Model
- AV-1010
- 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
- 4
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- fc627721-25ce-4265-a36e-1780ffdc5e8f
Device Description
Lead Adapter Replacement, Powder coated lead adapter with 7 ft. oxygen tube with secure fit connector
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
- Yes
- 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 |
|---|---|---|---|---|
| 12875 | Oxygen administration tubing | A length of flexible noninvasive tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2), or an O2 enriched gas, to a mask or nasal cannula (not included), during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857863007918 | GS1 |
Customer Contacts
- Phone
- 800-321-5981
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K865107 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- store at room temperature