FDA.reportPublic FDA data

Rymed

Primary DI
30817903010651
Brand
Rymed
Company
RYMED TECHNOLOGIES, LLC
Model
RYM-5000
Device description
InVision-Plus, Needleless IV Connector , in Touch Free Container
Published
2018-04-25
Public version status
Update
Distribution status
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
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
20817903010654PackageGS12In Commercial Distribution
30817903010651PackageGS15In Commercial Distribution
10817903010657PrimaryGS10
00817903010650Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081790301065420817903010654
3081790301065130817903010651
1081790301065710817903010657
00817903010650008179030106508179030106500817903010650

GMDN Terms#

Term, Definition table
TermDefinition
Neutral-pressure intravenous line needleless valve-connectorA small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point there is minimal fluid flow into or out of the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. 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
100
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
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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Primary DI, Brand, Company table
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05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
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05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
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