FDA UDI
In Commercial Distribution
🇺🇸 United States
Insta/Vent
DI: 00857863007352
·
Model: IV-601A
·
Medi/Nuclear Corporation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Insta/Vent
- Primary DI
- 00857863007352
- Version / Model
- IV-601A
- 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
- 2815998b-aa94-4c2f-8c2c-6c6bd66e59e0
Device Description
Insta/Vent Portable Shield, Aluminum Case
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 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 | 00857863007352 | GS1 |
Customer Contacts
- Phone
- 800-321-5981
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K960397 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- store at room temperature