Identity
- Trade Name
- ProTrach® HME 22 Regular FDA UDI
- Generic Name
- Tracheostomy tube speech valve FDA UDI
- Device Name
- The ProTrach HME 15 XtraMoist offers high humidification while the ProTrach HME 15/22 Regular offers a higher airflow. FDA UDI
- Model / Reference
- 7747 FDA UDI
- Description
- The ProTrach HME 15 XtraMoist offers high humidification while the ProTrach HME 15/22 Regular offers a higher airflow. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07331791008245 FDA UDI
- 510(k) Number
- K151404 FDA UDI
- FDA Product Code
- JOH FDA UDI
- GMDN Term
- Tracheostomy tube speech valve FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 22 Millimeter FDA UDI
ProTrach® HME 22 Regular by Atos Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K151404 also covers:
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
- Atos Medical Inc.
Sources (1)
- FDA UDI 6b814148-deb2-40cd-8023-966534074003 38 fields · synced Jun 8, 2026