Identity
- Trade Name
- MEDLINE INDUSTRIES, INC. FDA UDI
- Generic Name
- Nebulizing system delivery set, reusable FDA UDI
- Device Name
- DBD-COMPRESSOR,NEBULIZER FOR ROBERTS FDA UDI
- Model / Reference
- HCS60004R FDA UDI
- Description
- DBD-COMPRESSOR,NEBULIZER FOR ROBERTS FDA UDI
Identifiers
- Catalog Number
- HCS60004R FDA UDI
- Primary DI / UDI-DI
- 10080196666003 FDA UDI
- 510(k) Number
- K031413 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Nebulizing system delivery set, reusable 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
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
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nebulizing system delivery set, reusable
Medline Industries, Inc. by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nebulizing system delivery set, reusable.
- Omron Nosepiece for Nebulizer — Omron Healthcare, Inc. · Class II
- Nasoneb® — MONAGHAN MEDICAL CORP. · Class I
- Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II
- Nebulizer Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- Schuco — Allied Medical LLC · Class II
- Yirdoc — Qingdao Future Medical Technology Co., Ltd. · Class II
- VixOne™ Reusable Nebulizer — WESTMED, INC. · Class II
- Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II
Cleared under the same submission
K031413 also covers:
- LEADER — Cardinal Health 110, Inc.
- CARDINAL HEALTH — Cardinal Health 200, LLC
- DRIVEMEDICAL — Drive Devilbiss Healthcare
- DRIVEMEDICAL — Drive Devilbiss Healthcare
- DRIVEMEDICAL — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- JOHN BUNN — GF Health Products, Inc
- JOHN BUNN — GF Health Products, 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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 85dd70d4-c0b5-481c-aedd-53fe05cab5f4 36 fields · synced May 30, 2026