Identity
- Trade Name
- Forsure FDA UDI
- Generic Name
- Endobronchial tube FDA UDI
- Device Name
- A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device. FDA UDI
- Model / Reference
- 11220039 FDA UDI
- Description
- A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 11220039 FDA UDI
- Primary DI / UDI-DI
- 00815123012065 FDA UDI
- 510(k) Number
- K092886 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
Ethylene Oxide FDA UDI
Category: Endobronchial tube
Forsure by Forsure Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endobronchial tube.
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- Human-broncho endobronchial tube — INSUNG MEDICAL Co., Ltd.. · Class II
- Parker Flex-Tip — SALTER LABS · Class II
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- Endobronchial Tube — Well Lead Medical Co., Ltd · Class II
Cleared under the same submission
K092886 also covers:
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Parker — SALTER LABS
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
- Forsure Medical Products Llc
Sources (1)
- FDA UDI 45b6ab3f-3449-4d96-9258-59e38aef785a 37 fields · synced May 30, 2026