FDA.reportPublic FDA data

IV Plus®

Primary DI
10815879020953
Brand
IV Plus®
Company
STAR MOUNTAIN MEDICAL TECHNOLOGIES, INC.
Model
HS10022
Device description
22 Ga. X 1.00 in. (0.7 mm X 25 mm)
Published
2016-11-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30815879020957PackageGS125Not in Commercial Distribution
10815879020953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081587902095730815879020957
1081587902095310815879020953

GMDN Terms#

Term, Definition table
TermDefinition
Vascular port administration setA collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-866-336-3987TKOCUSTSERV@NEXUSMEDICAL.COM

Regulatory Flags#

DUNS number
080490186
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815879020878IV Plus®HS050192016-11-10
10815879020885IV Plus®HS050202016-11-10
10815879020892IV Plus®HS050222016-11-10
10815879020908IV Plus®HS075192016-11-10
10815879020915IV Plus®HS075202016-11-10
10815879020922IV Plus®HS075222016-11-10
10815879020939IV Plus®HS100192016-11-10
10815879020946IV Plus®HS100202016-11-10
10815879020960IV Plus®HS150192016-11-10
10815879020977IV Plus®HS150202016-11-10
10815879020984IV Plus®HS150222016-11-10
30815879020872IV Plus®HS050192016-11-10
30815879020889IV Plus®HS050202016-11-10
30815879020896IV Plus®HS050222016-11-10
30815879020902IV Plus®HS075192016-11-10
30815879020919IV Plus®HS075202016-11-10
30815978020926IV Plus®HS075222016-11-10
30815879020933IV Plus®HS100192016-11-10
30815879020940IV Plus®HS100202016-11-10
30815879020957IV Plus®HS100222016-11-10

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