Identity
- Trade Name
- Biotronix Healthcare FDA UDI
- Generic Name
- Nebulizing system delivery set, single-use FDA UDI
- Device Name
- Nebulizer with Adult Mask, 7ft. No Crush Tubing and Standard Connector FDA UDI
- Model / Reference
- RE-343002S FDA UDI
- Description
- Nebulizer with Adult Mask, 7ft. No Crush Tubing and Standard Connector FDA UDI
Identifiers
- Catalog Number
- RE-343002S FDA UDI
- Primary DI / UDI-DI
- 00850005165095 FDA UDI
- 510(k) Number
- K140237 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nebulizing system delivery set, single-use
Biotronix Healthcare by Biotronix Healthcare Industries Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K140237 also covers:
- Biotronis Healthcare — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Hippo Pediatric Nebulizer — Dynarex Corp.
- Portable Nebulizer — Dynarex Corp.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL 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
- Biotronix Healthcare Industries Inc.
Sources (1)
- FDA UDI 5bea9911-3b14-451c-bee9-f53db7f0029c 36 fields · synced May 30, 2026