FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 06938119326596
·
Model: Right:Fr35
·
Henan Tuoren Medical Device Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 06938119326596
- Version / Model
- Right:Fr35
- Company Name
- Henan Tuoren Medical Device Co.,Ltd.
- Labeler DUNS
- 526982680
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-01
- Public Version
- 1
- Public Version Date
- 2019-10-09
- Public Version Status
- New
- Public Device Record Key
- fb56f7cf-5e53-4319-8825-df2f22b2394d
Device Description
The Endobronchial tube contians 1Pc Fr35 Right Endobronchial tube,1Pc Multifunctional joint and 2Pcs Fr10 Suction catheter, 1Pc Fr16Suction catheter.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 | 16938119326593 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 06938119326596 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152251 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 35 | French |