Identity
- Trade Name
- Healthline, Medicator FDA UDI
- Generic Name
- Nebulizing system delivery set, single-use FDA UDI
- Device Name
- Convenience Kit: Portless Vinyl Mask (Adult) with Adapter (HL-22), Bacterial/Viral Filter, Ultra-Flex tubing (extends 6-24 inches), Aerosol Flow Tee, and End Cap. FDA UDI
- Model / Reference
- AM-608AK FDA UDI
- Description
- Convenience Kit: Portless Vinyl Mask (Adult) with Adapter (HL-22), Bacterial/Viral Filter, Ultra-Flex tubing (extends 6-24 inches), Aerosol Flow Tee, and End Cap. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850022357725 FDA UDI
- 510(k) Number
- K960397 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Nebulizing system delivery set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Nebulizing system delivery set, single-use
Healthline, Medicator by Medi Nuclear Corp., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 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.
- 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 69f2152d-2630-4826-bb82-1a795ef3aa6d 36 fields · synced May 30, 2026