FDA UDI
In Commercial Distribution
🇺🇸 United States
Pleura Med
DI: 07500463968372
·
Model: Adult
·
Solomed, S.A. de C.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pleura Med
- Primary DI
- 07500463968372
- Version / Model
- Adult
- Company Name
- Solomed, S.A. de C.V.
- Labeler DUNS
- 588625921
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-30
- Public Version
- 2
- Public Version Date
- 2020-01-08
- Public Version Status
- Update
- Public Device Record Key
- d5343ff1-aff5-4284-9e26-fe7a14e72f3d
Device Description
Equipment to drain the pleural cavity
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| KDQ | Bottle, Collection, Vacuum | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63652 | Thoracic suction collection container | A device intended to be connected between a thoracic drainage catheter (not included) and a suction wall outlet, to collect fluids (e.g., blood), secretions and/or air during controlled aspiration of the pleural cavity and/or mediastinum. The device typically incorporates three graduated chambers, designed for fluid collection, water seal, and suction control, and a suction regulator, air leak indicator, and connection tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07500463968372 | GS1 |