FDA UDI
In Commercial Distribution
🇺🇸 United States
BRONCHITRAC® "L" SET • 14 F
DI: 00888937017052
·
Model: 41-7814
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BRONCHITRAC® "L" SET • 14 F
- Primary DI
- 00888937017052
- Version / Model
- 41-7814
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-26
- Public Version
- 3
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- b46f6cec-b26c-4d37-a6cd-7a8fff28577c
Device Description
BRONCHITRAC® "L" SET • 14 F SELECTIVE LEFT BRONCHIAL SUCTIONING SET
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | 868.6810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35673 | Bronchial cannula | A sterile semi-rigid or rigid plastic or metal tube-shaped surgical instrument that is inserted into the lumen of the bronchus by means of a trocar providing rigidity. After insertion the trocar is withdrawn leaving a channel for suction or irrigation or the insertion of a catheter or surgical device. This device is single-use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30888937017053 | GS1 | 4 | In Commercial Distribution | ||
| Package | 20888937017056 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 00888937017052 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 14 | French |