FDA UDI
In Commercial Distribution
🇺🇸 United States
extriCARE
DI: 00879766005587
·
Model: EC2400-110V
·
OAKWELL DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- extriCARE
- Primary DI
- 00879766005587
- Version / Model
- EC2400-110V
- Company Name
- OAKWELL DISTRIBUTION, INC.
- Labeler DUNS
- 033337813
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-30
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9cd03293-49b2-4e45-a7d9-c7c679a5b6c0
Device Description
EC2400 adaper with US
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61258 | Multi-purpose low-vacuum suction system | An assembly of devices designed to generate a low vacuum [typically <400 millimetre(s) of mercury (mmHg)] for a variety of clinical applications (e.g., thoracic drainage, negative pressure wound therapy, endoluminal vacuum therapy, subglottic suctioning); it may be software limited to a single intended use whereby upgrade is possible. It consists of a mains electricity (AC-powered) suction pump (which may include a rechargeable battery) with software, controls, and a pressure regulator, a collection canister(s), tubing, and bacteria filter; it may also include patient contact devices. The low vacuum level is intended to reduce the risk of trauma. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10879766005584 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00879766005587 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110078 | 000 |