Identity
- Trade Name
- RUSCH FDA UDI
- Generic Name
- Laryngectomy tube FDA UDI
- Device Name
- Laryngectomy tube, cuffed FDA UDI
- Model / Reference
- IPN041899 FDA UDI
- Description
- Laryngectomy tube, cuffed FDA UDI
Identifiers
- Catalog Number
- 121181-000080 FDA UDI
- Primary DI / UDI-DI
- 04026704012916 FDA UDI
- FDA Product Code
- BTO FDA UDI
- GMDN Term
- Laryngectomy tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 8 Millimeter FDA UDIOuter Diameter — 11.4 Millimeter FDA UDI
Category: Laryngectomy tube
Rusch by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laryngectomy tube.
- OSSEOUS — EON MEDITECH PRIVATE LIMITED · Class I
- galemed — Galemed Corp. · Class I
- Singer Laryngectomy Tube — Boston Medical Products, Inc. · Class I
- OSSEOUS — EON MEDITECH PRIVATE LIMITED · Class I
- Singer Laryngectomy Tube — Boston Medical Products, Inc. · Class I
- InHealth Technologies — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies — FREUDENBERG MEDICAL, LLC · Class II
- Singer Laryngectomy Tube — Boston Medical Products, Inc. · Class I
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
- Teleflex Incorporated
Sources (1)
- FDA UDI 3525e123-a02c-47f5-a7f5-aa3033f0a8db 36 fields · synced May 30, 2026