Identity
- Trade Name
- RUSCH FDA UDI
- Generic Name
- Endobronchial tube FDA UDI
- Device Name
- BRONCHIAL DOUBLE LUMEN TUBE SET (LEFT), STERILE FDA UDI
- Model / Reference
- IPN041703 FDA UDI
- Description
- BRONCHIAL DOUBLE LUMEN TUBE SET (LEFT), STERILE FDA UDI
Identifiers
- Catalog Number
- 116100410 FDA UDI
- Primary DI / UDI-DI
- 14026704344250 FDA UDI
- 510(k) Number
- K141888 FDA UDI
- FDA Product Code
- CBI FDA UDI
- GMDN Term
- Endobronchial tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5740 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 — 340 Millimeter FDA UDI
Category: Endobronchial tube
Rusch by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endobronchial tube.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
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- Parker Flex-Tip — SALTER LABS · Class II
- Mallinckrodt — Covidien LP · Class II
- Endobronchial Tube — Well Lead Medical Co., Ltd · Class II
- SILBRONCHO (RIGHT LUNG) — Fuji Systems Corp. · Class II
- UNIVENT TUBE (TCB TYPE) — Fuji Systems Corp. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K141888 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 d30f464d-25e8-471d-b6a8-6f7f4f8f6054 36 fields · synced May 30, 2026