FDA UDI
In Commercial Distribution
🇺🇸 United States
RIVA
DI: 00691794010001
·
Model: 100000
·
ARxIUM Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RIVA
- Primary DI
- 00691794010001
- Version / Model
- 100000
- Catalog Number
- CON-0100-9
- Company Name
- ARxIUM Inc
- Labeler DUNS
- 202676839
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-10
- Public Version
- 4
- Public Version Date
- 2020-01-24
- Public Version Status
- Update
- Public Device Record Key
- 815ac811-39b4-4a6e-9d74-0aacfb7442c2
Device Description
A device used to prepare IV bags and syringes for hospital and compounding pharmacies.
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 |
|---|---|---|---|---|
| NEP | System/Device, Pharmacy Compounding | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33963 | Peripheral intravenous catheterization support kit | A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00691794010001 | GS1 |
Customer Contacts
- Phone
- 847-495-3140
- [email protected]
- Phone
- 414-708-0199
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Spare Parts shall be kept in original packaging and if electronically sensitive devices are handled, ESD (Electrostatic Discharge) controls shall be in place.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Products must not be stored in a direct drainage path and must not be stored directly adjacent to any sinks or floor drains, thereby reducing the risk of water damage
- Type
- Special Storage Condition, Specify
- Special Conditions
- The roof, walls and floors of the storage facility must be impervious and free from leaks
- Type
- Special Storage Condition, Specify
- Special Conditions
- The area must be clean and the surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the surrounding area shall be smooth, free from cracks and crevices, and non-shedding,
- Type
- Special Storage Condition, Specify
- Special Conditions
- The site should have evidence of a pest control program to prevent contamination
- Type
- Special Storage Condition, Specify
- Special Conditions
- The area shall not contain any doors that connect to the outdoors or areas of high traffic flow, or that are adjacent to construction sites, warehouses, or food preparation
- Type
- Special Storage Condition, Specify
- Special Conditions
- The area shall not contain any unsealed windows
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 81.2 – 101 KiloPascal