FDA UDI
In Commercial Distribution
🇺🇸 United States
EXPRESS
DI: 00650862164008
·
Model: 16400
·
Atrium Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EXPRESS
- Primary DI
- 00650862164008
- Version / Model
- 16400
- Company Name
- Atrium Medical Corporation
- Labeler DUNS
- 051798999
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 7
- Public Version Date
- 2023-12-01
- Public Version Status
- Update
- Public Device Record Key
- 00739cb5-22b0-4917-b6ad-87e063d49a30
Device Description
EXPRESS MINI 500 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
- MR Conditional
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 20650862164002 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 00650862164008 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K984496 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 44.6 – 113 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity