FDA.reportPublic FDA data

SECURE®

Primary DI
50812496011763
Brand
SECURE®
Company
METRIX COMPANY, THE
Model
66410
Catalog number
66410
Device description
EMPTY EVA CONTAINER With Male Screw Connector
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPEContainer, I.V.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPEContainer, I.V.General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030888000EVA EMPTY SOLUTION CONTAINERMetrix Co.2003-04-02KPE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50812496011763PackageGS150In Commercial Distribution
00812496011763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081249601176350812496011763
00812496011763008124960117638124960117630812496011763

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous fluid container, single-useA container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravenous (IV) administration set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume500Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8007523148support@metrixco.com

Regulatory Flags#

DUNS number
043046283
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
false
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
00812496011893SECURE®58784587842016-09-24
00812496011213CORMIXMS64135MS641352016-09-24
00812496011275CORMIXMS64235MS642352016-09-24
00812496011923CORMIXMS64783MS647832016-11-09
20812496011811SECURE®66651666512016-09-24
20812496011828SECURE®66652666522016-09-24
20812496011835SECURE®66653666532016-09-24
20812496011842SECURE®66654666542016-09-24
20812496011477SECURE®66616666162016-09-24
20812496011514SECURE®66631666312016-09-24
20812496011538SECURE®66641666412016-09-24
00812496011466SECURE®66615666152016-09-24
00812496011503SECURE®66630666302016-09-24
00812496011527SECURE®66640666402016-09-24
00812496011619SECURE®66100661002016-09-24
00812496011626SECURE®66102661022016-09-24
00812496011633SECURE®66105661052016-09-24
00812496011640SECURE®66110661102016-09-24
00812496011657SECURE®66120661202016-09-24
00812496011664SECURE®66125661252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00075289522178ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522185ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522192ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522208ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522215ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522222ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522239ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522246ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-22
00075289522253ISO-MEDTRANZONIC COMPANIES, THEKPE2026-06-10
18859299123612eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299123629eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299123636eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
18859299124589eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2026-04-10
08056209145105EVA TPN BAGSVALMED SRLKPE2026-02-02
08056209145112EVA TPN BAGSVALMED SRLKPE2026-02-02
18033737862282EVA TPN BagsVALMED SRLKPE2025-12-31
10748426139726Medline-MicrotekMicrotek Medical LLCKPE2025-10-10
10748426139672Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
10748426139719Medline-MicrotekMicrotek Medical LLCKPE2025-10-08
18859299136131eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
18859299136148eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
18859299136155eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-09-11
20192253056706ChemoPlusCardinal Health 200, LLCKPE2025-08-22
20192253056713ChemoPlusCardinal Health 200, LLCKPE2025-08-22
18859299136179eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-07-31
18859299136032eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136049eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136063eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136070eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06
18859299136087eZSURE™EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKPE2025-06-06