AccessGUDID - DEVICE: RIVA (00691794010001)

GUDID

Device Identifier (DI) Information

Brand Name: RIVA
Version or Model: 100000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CON-0100-9
Company Name: ARxIUM Inc

Primary DI Number: 00691794010001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 202676839 *Terms of Use

Device Description: A device used to prepare IV bags and syringes for hospital and compounding pharmacies.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NEP	System/Device, Pharmacy Compounding

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Spare Parts shall be kept in original packaging and if electronically sensitive devices are handled, ESD (Electrostatic Discharge) controls shall be in place.
Special Storage Condition, Specify: 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
Special Storage Condition, Specify: The roof, walls and floors of the storage facility must be impervious and free from leaks
Special Storage Condition, Specify: 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,
Special Storage Condition, Specify: The site should have evidence of a pest control program to prevent contamination
Special Storage Condition, Specify: 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
Special Storage Condition, Specify: The area shall not contain any unsealed windows
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 81.2 and 101 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 815ac811-39b4-4a6e-9d74-0aacfb7442c2
Public Version Date: January 24, 2020
Public Version Number: 4
DI Record Publish Date: September 10, 2016