FDA.reportPublic FDA data

RIVA

Primary DI
00691794010001
Brand
RIVA
Company
ARxIUM Inc
Model
100000
Catalog number
CON-0100-9
Device description
A device used to prepare IV bags and syringes for hospital and compounding pharmacies.
Published
2016-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEPSystem/Device, Pharmacy Compounding

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEPSystem/Device, Pharmacy CompoundingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00691794010001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00691794010001006917940100016917940100010691794010001

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral intravenous catheterization support kitA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure81.2 KiloPascal101 KiloPascal
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Handling Environment Temperature20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Special Storage Condition, Specify00Products 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, Specify00Spare 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, Specify00The 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, Specify00The 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, Specify00The area shall not contain any unsealed windows
Special Storage Condition, Specify00The roof, walls and floors of the storage facility must be impervious and free from leaks
Special Storage Condition, Specify00The site should have evidence of a pest control program to prevent contamination

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
847-495-3140cross@arxium.com
414-708-0199mmani@arxium.com

Regulatory Flags#

DUNS number
202676839
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
01691794010001RIVA100000CON-0100-92016-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887709126503ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-06-24
00887709170995ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-06-02
00887709098602ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-05-28
00887709166288ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709166295ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709166318ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709170988ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709127371ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127388ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127395ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127432ICU Medical, IncICU MEDICAL, INC.NEP2026-04-01
00887709125995ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-01-12
00887709167216ICU Medical, Inc.ICU MEDICAL, INC.NEP2025-10-20
00860001977356OnsetOnpharma CompanyNEP2025-09-19
00085412169286DUO-VENTBaxter Healthcare SANEP2025-03-20
50085412169281DUO-VENTBaxter Healthcare SANEP2025-03-20
00860006285043IVX ManagerOmnicell, Inc.NEP2024-05-10
00840619054908DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619065058DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619089894DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619090876DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619091590DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00850033629408Acta MedicalActa Medical LLCNEP2024-02-14
00860006285036IVX CloudOmnicell, Inc.NEP2024-01-10
08426314948258GRI-FILLLABORATORIOS GRIFOLS SANEP2023-07-19
00887709125117DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125124DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125131DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125735DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126497DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10