FDA UDI
In Commercial Distribution
🇺🇸 United States
UMF Medical
DI: 00815235021375
·
Model: SS8345
·
UNITED METAL FABRICATORS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UMF Medical
- Primary DI
- 00815235021375
- Version / Model
- SS8345
- Company Name
- UNITED METAL FABRICATORS, INC.
- Labeler DUNS
- 004324596
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 2
- Public Version Date
- 2020-10-16
- Public Version Status
- Update
- Public Device Record Key
- 62f159dc-64fe-4154-a55c-e6a4171b7acd
Device Description
Stainless Steel 2 Hook Infusion Pump IV Pole
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FOX | Stand, Infusion | General Hospital | 880.6990 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61153 | Infusion/transfusion trolley | A cart designed to accommodate the equipment necessary for infusion/transfusion of intravenous products. The trolley will typically have stands, hangers, drawers, and/or shelves to hold equipment and tubing during the treatment process. It may be equipped with additional elements such as trays, needle, and/or catheter containers and clinical waste bins. It is intended to be used in clinical environments where transfusion/infusion procedures occur [e.g., a blood transfusion centre, intensive care unit (ICU), and accident and emergency (A&E) unit]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815235021375 | GS1 |