FDA.reportPublic FDA data

STOPCOCKS

Primary DI
00886333201433
Brand
STOPCOCKS
Company
ARGON MEDICAL DEVICES, INC.
Model
041216810A
Catalog number
041216810A
Device description
Stopcocks. One Way Stopcock W/Male Luer Lock. Ports Without covers.
Published
2015-10-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOCAccessories, Blood Circuit, Hemodialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOCAccessories, Blood Circuit, HemodialysisGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K770383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K770383000STOPCOCK, ONE WAYCobe Laboratories, Inc.1977-03-07KOC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333201437PackageGS1500In Commercial Distribution
00886333201433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633320143720886333201437
00886333201433008863332014338863332014330886333201433

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886333003594Breast Localization Needles231075G231075G2022-07-05
00886333003600Breast Localization Needles231030G231030G2022-07-05
00886333003617Breast Localization Needles231050G231050G2022-07-05
00886333003624Breast Localization Needles231125G231125G2022-07-05
00886333003631Breast Localization Needles231100G231100G2022-07-05
00886333003648Breast Localization Needles2420502420502022-06-30
00886333003655Breast Localization Needles2420752420752022-06-30
00886333003662Breast Localization Needles2421002421002022-06-30
00886333003679Breast Localization Needles2421252421252022-06-29
00886333003686Breast Localization Needles2430752430752022-06-29
00886333003693Breast Localization Needles2431252431252022-07-05
00886333003709Breast Localization Needles2430502430502022-06-29
00886333003723Breast Localization Needles2430302430302022-06-29
00886333003730Breast Localization Needles2440302440302022-06-30
00886333003747Breast Localization Needles2440502440502022-06-30
00886333003754Breast Localization Needles2440752440752022-06-29
00886333003761Breast Localization Needles2441002441002022-06-30
00886333003778Breast Localization Needles2441252441252022-06-30
00886333003785Breast Localization Needles2511002511002022-06-29
00886333003792Breast Localization Needles2510752510752022-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842289103689System One Cycler BaseNXSTAGE MEDICAL, INC.KOC2026-04-22
00842289103696Extended Cycler Base and Filter HolderNXSTAGE MEDICAL, INC.KOC2026-04-22
00842289103702Fluid Detection SystemNXSTAGE MEDICAL, INC.KOC2026-04-22
04987671100627Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
24987671100621Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
04987671100658Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
008408611023655008X HDF Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611023725008X HDF Hemodialysis Blood Tubing Set with CLiC Blood ChamberFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611023895008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (TwFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611024645008X Fluid Sampling AccessoryFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023625008X HDF Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023795008X HDF Hemodialysis Blood Tubing Set with CLiC Blood ChamberFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023865008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (TwFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611024615008X Fluid Sampling AccessoryFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
04987671400000Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2023-08-28
B144MPC825S0Molded Products, Inc.MOLDED PRODUCTS, INC.KOC2022-10-04
B144MPC825S1Molded Products, Inc.MOLDED PRODUCTS, INC.KOC2022-10-04
00840861102259CombiSet SMARTECHFresenius Medical Care Renal Therapies Group, LLCKOC2020-11-17
00840861102266CombiSet SMARTECHFresenius Medical Care Renal Therapies Group, LLCKOC2020-11-17
04987671201102BLOOD TUBING LINES FOR HEMODIALYSISNIKKISO CO.,LTD.KOC2020-10-30
24987671201106BLOOD TUBING LINES FOR HEMODIALYSISNIKKISO CO.,LTD.KOC2020-10-30
00842289102613Dialysis Priming SetNXSTAGE MEDICAL, INC.KOC2020-10-06
10842289102610Dialysis Priming SetNXSTAGE MEDICAL, INC.KOC2020-10-06
00865165000209HemoBandINNOVATIONS FOR ACCESS INCKOC2020-09-12
00865165000216HemoBandINNOVATIONS FOR ACCESS INCKOC2020-09-12
00865165000223HemoBandINNOVATIONS FOR ACCESS INCKOC2020-09-03
0088893702095316G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04
0088893702096016G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04
0088893702099117G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04
0088893702100417G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04