FDA.reportPublic FDA data

Rymed

Primary DI
00817903010247
Brand
Rymed
Company
RYMED TECHNOLOGIES, LLC
Model
RYM-7307HP
Device description
"7"" MacroBore High Pressure Catheter Extension Set with InVision-Plus CS"
Published
2018-10-22
Public version status
Update
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991653000INVISION-PLUS INJECTION PORT CONNECTOR SYSTEMRymed Technologies, Inc.1999-06-24FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817903010244PackageGS1100In Commercial Distribution
20817903010241PackageGS14In Commercial Distribution
00817903010247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081790301024410817903010244
2081790301024120817903010241
00817903010247008179030102478179030102470817903010247

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+15123017334amccutchen@rymedtech.com

Regulatory Flags#

DUNS number
079219081
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817903010865RyMedRYM-3060P2024-02-21
00817903010872RyMedRYM-3360P2024-02-21
10817903010862RyMedRYM-3060P2024-02-21
10817903010879RyMedRYM-3360P2024-02-21
10817903010657RymedRYM-50002018-04-25
10817903010664RymedRYM-5000CL2018-04-25
10817903010671RymedRYM-70002018-04-25
10817903010688Rymed4153012018-04-25
10817903010695Rymed4153002018-04-25
10817903010701Rymed4153042018-04-25
00817903010001RymedRYM-50012016-09-26
00817903010018RymedRYM-5001CL2018-10-22
00817903010025RymedRYM-70012018-04-25
00817903010032RymedRYM-80012018-04-25
00817903010049Rymed4153032018-04-25
00817903010056RymedRYM-20012018-04-25
00817903010063Rymed4153022018-04-25
00817903010070Rymed4153052018-04-25
00817903010087RymedRYM-50002018-11-02
00817903010094RymedRYM-5000CL2018-11-02

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05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
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05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
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05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018633LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
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04046955836383Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15
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00085412676630DUO-VENTBAXTER HEALTHCARE CORPORATIONFPA2023-07-11
00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06