FDA.reportPublic FDA data

IV Plus®

Primary DI
30815879020889
Brand
IV Plus®
Company
STAR MOUNTAIN MEDICAL TECHNOLOGIES, INC.
Model
HS05020
Device description
20 Ga. X 0.50 in. (0.9 mm X 13 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
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142590000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142590000All Safe Huber Safety Infusion SetNexus Medical, LLC2015-01-16FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30815879020889PackageGS125Not in Commercial Distribution
10815879020885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081587902088930815879020889
1081587902088510815879020885

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080490186
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10815879020953IV Plus®HS100222016-11-10
10815879020960IV Plus®HS150192016-11-10
10815879020977IV Plus®HS150202016-11-10
10815879020984IV Plus®HS150222016-11-10
30815879020872IV Plus®HS050192016-11-10
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
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00811505030573IvenixFresenius Kabi AGFPA2026-06-02
04046955836383Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15