RIVA

Primary DI
01691794010001
Brand
RIVA
Company
ARxIUM Inc
Model
100000
Catalog number
CON-0100-9
Device description
A device use to prepare IV’s and syringes for hospital pharmacies.
Published
2016-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
01691794010001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
01691794010001016917940100011691794010001

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
204 594 5319blalo@arxium.com

Regulatory Flags#

DUNS number
202676839
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00691794010001RIVA100000CON-0100-92016-09-10

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Primary DI, Brand, Company table
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