FDA UDI
In Commercial Distribution
🇺🇸 United States
Infusion stand rotating
DI: 07350111831035
·
Model: 10-400-US
·
Reison Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Infusion stand rotating
- Primary DI
- 07350111831035
- Version / Model
- 10-400-US
- Company Name
- Reison Medical AB
- Labeler DUNS
- 356766220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-30
- Public Version
- 1
- Public Version Date
- 2022-05-09
- Public Version Status
- New
- Public Device Record Key
- ff6f537a-8862-4ad5-8f07-ada5e678cf2d
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
- 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 |
|---|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | 878.4950 | 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 | 07350111831035 | GS1 |