FDA UDI
Not in Commercial Distribution
🇺🇸 United States
EXPRESS
DI: 00650862115215
·
Model: 4020-100N
·
Atrium Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EXPRESS
- Primary DI
- 00650862115215
- Version / Model
- 4020-100N
- Company Name
- Atrium Medical Corporation
- Labeler DUNS
- 051798999
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 4
- Public Version Date
- 2020-10-15
- Public Version Status
- Update
- Public Device Record Key
- 9bd57d3b-8743-42b8-936f-662b3e306a13
- Distribution End Date
- 2017-10-31
Device Description
EXPRESS, Dual Collection (Express Dry Seal Chest Drain)
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
- 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
- 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 |
|---|---|---|---|---|
| KDQ | Bottle, Collection, Vacuum | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36787 | Thoracic suction system | An assembly of devices designed to evacuate large volumes of fluid and/or air accumulated between the lung and chest wall (pleural space) by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system is usually employed following thoracic surgery, traumatic chest wounds, barotrauma, or pleural effusions. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20650862115219 | GS1 | 6 | Not in Commercial Distribution | 2017-10-31 | |
| Primary | 00650862115215 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K043140 | 000 |