Identity
- Trade Name
- Insta/Vent FDA UDI
- Generic Name
- Teletherapy radionuclide system table, non-powered FDA UDI
- Device Name
- Insta/Vent Mobile Cabinet. (For Insta/Vent Lead Shield). Mobile Cabinet constructed of wood and almond color formica. Includes sliding shelf that locks lead shield in place and brings it close to a patient, decay leaded area, storage area for supplies, swivel casters with front brakes. Oxygen tank is optional. FDA UDI
- Model / Reference
- IV-603 FDA UDI
- Description
- Insta/Vent Mobile Cabinet. (For Insta/Vent Lead Shield). Mobile Cabinet constructed of wood and almond color formica. Includes sliding shelf that locks lead shield in place and brings it close to a patient, decay leaded area, storage area for supplies, swivel casters with front brakes. Oxygen tank is optional. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857863007383 FDA UDI
- 510(k) Number
- K960397 FDA UDI
- FDA Product Code
- IYT FDA UDI
- GMDN Term
- Teletherapy radionuclide system table, non-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 139 Pound FDA UDIHeight — 39 Inch FDA UDIDepth — 15.25 Inch FDA UDIWidth — 20.75 Inch FDA UDI
Category: Teletherapy radionuclide system table, non-powered
Insta/Vent by Medi Nuclear Corp., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Teletherapy radionuclide system table, non-powered.
Cleared under the same submission
K960397 also covers:
- Healthline, ARK - Asthma Rescue Kit, Mix & Mount — MEDI NUCLEAR CORP., INC.
- Healthline, Medicator — MEDI NUCLEAR CORP., INC.
- Healthline, Medicator — MEDI NUCLEAR CORP., INC.
- Healthline, Medicator Maximizer — MEDI NUCLEAR CORP., INC.
- Healthline, Medicator Maximizer — MEDI NUCLEAR CORP., INC.
- Healthline, Medicator Maximizer Plus — MEDI NUCLEAR CORP., INC.
- Healthline, Medicator Maximizer Plus — MEDI NUCLEAR CORP., INC.
- Healthline, Medicator Maximizer Plus — MEDI NUCLEAR CORP., INC.
- Healthline, Medicator Maximizer, Methacholine — MEDI NUCLEAR CORP., INC.
- Insta/Vent — MEDI NUCLEAR CORP., INC.
- Insta/Vent — MEDI NUCLEAR CORP., INC.
- Insta/Vent — MEDI NUCLEAR CORP., INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medi Nuclear Corp., Inc.
Sources (1)
- FDA UDI fe67e772-d665-43d2-9e77-0e6b892865ea 37 fields · synced May 29, 2026