Identity
- Trade Name
- NebuTech® FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Device Name
- NebuTech® HDN® Nebulizer with inhalation Valve and Pediatric I-Guard™ Valved Mask Aerosol Delivery System (vinyl). 7’ (2.1 m) tubing and mouthpiece with valve. FDA UDI
- Model / Reference
- 8967-7 FDA UDI
- Description
- NebuTech® HDN® Nebulizer with inhalation Valve and Pediatric I-Guard™ Valved Mask Aerosol Delivery System (vinyl). 7’ (2.1 m) tubing and mouthpiece with valve. FDA UDI
Identifiers
- Catalog Number
- 8967-7 FDA UDI
- Primary DI / UDI-DI
- 00607411891830 FDA UDI
- 510(k) Number
- K961476 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Therapeutic agent nebulizer, benchtop 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
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: Therapeutic agent nebulizer, benchtop
NebuTech® by Salter Labs — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Therapeutic agent nebulizer, benchtop.
- InnoSpire Essence — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
- Sidestream — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- AirLife™ — Airlife, Inc. · Class II
- AirLife™ — VYAIRE MEDICAL, INC. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- InnoSpire Elegance — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Salter Labs
Sources (1)
- FDA UDI 8c46b278-1ac0-4461-92ec-d7263a10a454 38 fields · synced May 30, 2026