FDA UDI
In Commercial Distribution
🇺🇸 United States
SimplFusor
DI: 68859299117524
·
Model: 480046BAX
·
EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
Basic Information
- Brand Name
- SimplFusor
- Primary DI
- 68859299117524
- Version / Model
- 480046BAX
- Company Name
- EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
- Labeler DUNS
- 662213220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2024-05-31
- Public Version
- 1
- Public Version Date
- 2024-06-10
- Public Version Status
- New
- Public Device Record Key
- 09204654-4faf-4fca-a12c-6390ce3cd6e9
Device Description
SimplFusor 270-10-27h
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
- 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 |
|---|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46542 | Elastomeric infusion pump system | An assembly of devices that provides continuous and/or intermittent percutaneous infusion of a prescribed medicated solution to a patient through forces from elastic material. It typically consists of an elastomeric chamber (various sizes predetermine the flow and volume) that is filled with the solution using a dedicated filling device and/or syringe to create a pressure, tubing, particulate/air-eliminating filter, a flow restrictor, and a connector at the distal end for connection to the patient's access device. It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 98859299117525 | GS1 | Carton | 48 | In Commercial Distribution | |
| Primary | 68859299117524 | GS1 | ||||
| Unit of Use | 78859299117521 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151650 | 000 |