Identity
- Trade Name
- JOHN BUNN FDA UDI
- Generic Name
- Nasal aspirator, electric FDA UDI
- Device Name
- ASPIRATOR W/ DLX STAND FDA UDI
- Model / Reference
- S131 FDA UDI
- Description
- ASPIRATOR W/ DLX STAND FDA UDI
Identifiers
- Catalog Number
- S131 FDA UDI
- Primary DI / UDI-DI
- M368S1311 FDA UDI
- 510(k) Number
- K042349 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Nasal aspirator, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
No
FDA UDI
Category: Nasal aspirator, electric
John Bunn by GF Health Products, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K042349 also covers:
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- Schuco — Allied Medical LLC
- Schuco — Allied Medical LLC
- Schuco — Allied Medical LLC
- Schuco — Allied Medical LLC
- Schuco — Allied Medical LLC
- Schuco — Allied Medical LLC
- DRIVEMEDICAL — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
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- Resp-O2 Suction Unit, Vacuum Levels up to 560 mmHg — Dynarex Corp.
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
- GF Health Products, Inc
Sources (1)
- FDA UDI 289f696c-6793-41e3-bcca-83550aafc26d 36 fields · synced Jun 8, 2026