Identity
- Trade Name
- RUSCH FDA UDI
- Generic Name
- Reinforced endotracheal tube, single-use FDA UDI
- Device Name
- Armoured tracheal tube, cuffed FDA UDI
- Model / Reference
- IPN040995 FDA UDI
- Description
- Armoured tracheal tube, cuffed FDA UDI
Identifiers
- Catalog Number
- 104004-000070 FDA UDI
- Primary DI / UDI-DI
- 04026704005550 FDA UDI
- 510(k) Number
- K955495 FDA UDI
- FDA Product Code
- BTR FDA UDI
- GMDN Term
- Reinforced endotracheal tube, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5730 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
No
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 — 7 Millimeter FDA UDIOuter Diameter — 9.8 Millimeter FDA UDI
Category: Reinforced endotracheal tube, single-use
Rusch by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reinforced endotracheal tube, single-use.
- Rurka intubacyjna bez mankietu — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa
- Disposable Tracheal tubes — Shaoxing Carere Medical Appliance Co., Ltd. · Class IIa
- Disposable Tracheal Tubes With Cuff — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- cuff — Contec Medical Systems Co., Ltd. · Class I
- Welllead Reinforced Tracheal Tube — Well Lead Medical Co., Ltd · Class IIa
- Disposable Endotracheal Tubes — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
- Endotracheal Tube — HANGZHOU FORMED MEDICAL DEVICES CO., LTD. · Class IIa
- Rurka intubacyjna z mankietem — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa
Cleared under the same submission
K955495 also covers:
- FORWARD Field Intubation Kit 7.5 — INTEGRATED MEDCRAFT LLC
- FORWARD Field Intubation Kit 8.0 — INTEGRATED MEDCRAFT LLC
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
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
- Teleflex Incorporated
Sources (1)
- FDA UDI 3267f58d-f0b1-4e38-bc71-9e4b99aad3ae 38 fields · synced May 30, 2026