FDA UDI
In Commercial Distribution
🇺🇸 United States
UNIVENT TUBE (TCB TYPE)
DI: 04544050123808
·
Model: I.D. 3.5MM, WITHOUT CUFF
·
FUJI SYSTEMS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- UNIVENT TUBE (TCB TYPE)
- Primary DI
- 04544050123808
- Version / Model
- I.D. 3.5MM, WITHOUT CUFF
- Catalog Number
- 1202716
- Company Name
- FUJI SYSTEMS CORPORATION
- Labeler DUNS
- 715919973
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-05
- Public Version
- 1
- Public Version Date
- 2023-09-13
- Public Version Status
- New
- Public Device Record Key
- 93c8241b-e20d-43d7-8ae6-896e132d1004
Device Description
ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | Anesthesiology | 868.5740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31328 | Endobronchial tube | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14544050123805 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 04544050123808 | GS1 | ||||
| Previous | 04544050055154 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K894337 | 000 |