FDA.reportPublic FDA data

KENAFLEXX

Primary DI
10852244007058
Brand
KENAFLEXX
Company
KENTRON HEALTHCARE, INC.
Model
943371
Catalog number
943371
Device description
I.V. EXTENSION SET Y-TYPE WITH 2 KEN_SEF CONNECTORS 5.7" LONG
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852244007058PackageGS1100In Commercial Distribution
00852244007051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085224400705810852244007058
00852244007051008522440070518522440070510852244007051

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5.7Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
615-384-0573kentron@kentronmedical.com

Regulatory Flags#

DUNS number
618825723
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
true
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
10810003751031KENOREX8044122024-04-14
10810003751048KENOREX8044142024-04-14
10810003751055KENOREX8044162024-04-14
10810003751062KENOREX8044182024-04-14
10810003751079KENOREX8044202024-04-14
10810003751086KENOREX8044222024-04-14
10810003751093KENOREX8044242024-04-14
10810003751109KENOREX8044262024-04-14
10810003751116KENOREX8044282024-04-14
10810003751123KENOREX8044302024-04-14
10810003751130KENOREX8044322024-04-14
10810003751147KENOREX8044342024-04-14
10810003751154KENOREX8044362024-04-14
00810003754301KENTEX8264122024-03-02
00810003754332KENTEX8264142024-03-02
00810003754363KENTEX8264162024-03-02
00810003754394KENTEX8264182024-03-02
00810003754424KENTEX8264202024-03-02
00810003754455KENTEX8264222024-03-02
00810003754486KENTEX8264242024-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290108241518Vial2Bag Advanced 20mm Admixture DeviceWEST PHARMA. SERVICES IL, . LTDLHI2026-03-17
00827989007970Chemo VentHealth Care Logistics, Inc.LHI2026-03-04
00827989007987Venting NeedleHealth Care Logistics, Inc.LHI2026-03-04
28699443581892FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443581915FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443581922FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585296FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585302FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585319FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585326FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
28699443585333FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
00827989007826SuregripHealth Care Logistics, Inc.LHI2025-12-19
00827989007833SuregripHealth Care Logistics, Inc.LHI2025-12-19
00850025688291HyHub Vial Access DeviceTakeda Pharmaceuticals U.S.A., Inc.LHI2025-09-23
00850025688963HyHub Duo Vial Access DeviceTakeda Pharmaceuticals U.S.A., Inc.LHI2025-09-23
04063574200425nextaro® va 13, 5 µm Filtersfm medical devices GmbHLHI2025-09-05
20851891007609ArisureYUKON MEDICAL, LLCLHI2025-06-30
20851891007623ArisureYUKON MEDICAL, LLCLHI2025-05-23
10851891007299ArisureYUKON MEDICAL, LLCLHI2025-05-14
10851891007305ArisureYUKON MEDICAL, LLCLHI2025-05-14
10810110921389Mini Transfer PinMPS Pharma & Medical, Inc.LHI2025-04-28
10887709128009ICU Medical, Inc.ICU MEDICAL, INC.LHI2025-04-25
00860007260421IVX Station Reconstitution Transfer SetOmnicell, Inc.LHI2025-01-23
10851891007329ArisureYUKON MEDICAL, LLCLHI2024-11-27
10851891007350ArisureYUKON MEDICAL, LLCLHI2024-11-27
00347426505086ZYNRELEF 10 mL Vial Access Needle (VAN) ReplacementHeron Therapeutics, Inc.LHI2024-11-07
00347426506083ZYNRELEF 20 mL Vial Access Needle (VAN) ReplacementHeron Therapeutics, Inc.LHI2024-11-07
28699443580178FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-10-07
30815879021749IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
30815879021756IV PlusNEXUS MEDICAL, LLCLHI2024-09-16