Identity
- Trade Name
- Healthline FDA UDI
- Generic Name
- Aerosol face mask, rebreathing, single-use FDA UDI
- Device Name
- Face Mask, Pediatric (size 2), Air-Cushioned, 22mm ID FDA UDI
- Model / Reference
- MN4046 FDA UDI
- Description
- Face Mask, Pediatric (size 2), Air-Cushioned, 22mm ID FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857863007567 FDA UDI
- FDA Product Code
- BSJ FDA UDI
- GMDN Term
- Aerosol face mask, rebreathing, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5550 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Aerosol face mask, rebreathing, single-use
Healthline by Medi Nuclear Corp., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- System 22 — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Medi Nuclear Corp., Inc.
Sources (1)
- FDA UDI 944a92fc-5d11-45d6-9659-c4be1c203ca0 35 fields · synced May 31, 2026