Identity
- Trade Name
- RUSCH FDA UDI
- Generic Name
- Reinforced endotracheal tube, single-use FDA UDI
- Device Name
- CURVED REINFORCED ENDOTRACEAL TUBE - MURPHY EYE, HIGH VOLUME, LOW PRESSURE CUFF - STERILE PACK FDA UDI
- Model / Reference
- IPN928688 FDA UDI
- Description
- CURVED REINFORCED ENDOTRACEAL TUBE - MURPHY EYE, HIGH VOLUME, LOW PRESSURE CUFF - STERILE PACK FDA UDI
Identifiers
- Catalog Number
- 103902050 FDA UDI
- Primary DI / UDI-DI
- 14026704917652 FDA UDI
- 510(k) Number
- K990619 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
- Length — 321 Millimeter FDA UDIWidth — 25 Millimeter FDA UDIOuter Diameter — 7.3 Millimeter FDA UDIHeight — 21 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
- Disposable Endotracheal Tube — Tianjin Plastics Research Institute Co., Ltd. · Class IIa
- 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
Cleared under the same submission
K990619 also covers:
- 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
- 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 |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI dd02d7df-ad8e-402f-a9d9-9668dafebfd6 37 fields · synced May 30, 2026