FDA UDI
In Commercial Distribution
🇺🇸 United States
LungVision Tool
DI: 07290017652108
·
Model: Bridge
·
BODY VISION MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LungVision Tool
- Primary DI
- 07290017652108
- Version / Model
- Bridge
- Catalog Number
- LV2055011
- Company Name
- BODY VISION MEDICAL LTD
- Labeler DUNS
- 600280073
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-11
- Public Version
- 2
- Public Version Date
- 2022-05-27
- Public Version Status
- Update
- Public Device Record Key
- 7ffcb56d-0878-4f9a-9725-02bf350df77b
Device Description
The LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area, specifically within the respiratory system. LungVision Tool, LV2055011 is compatible with Olympus Bronchoscope BF-1TH190 LungVision Tool composed from: LungVision Handle, LungVision Adaptor with seal for Olympus Bronchoscope BF-1TH190, LungVision J Curved Sheath and LungVision Stylet
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 |
|---|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57786 | Bronchoscopic catheter | A sterile, flexible, single lumen tube designed to be used as a conduit to the lung(s) for the delivery of another device (e.g., an emphysematous lung sealant) during a bronchoscopic procedure. It is typically made of synthetic materials that resist kinking (may be capable of bending 135 degrees or more without kinking) and is advanced through the working channel of a bronchoscope to the treatment site by the operator, typically a pulmonologist or thoracic surgeon. The distal tip may be marked with a band to facilitate visualization by the operator during the procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017652108 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172955 | 000 |