FDA.report

KENAFLEXX

Primary DI
00852244007044
Brand
KENAFLEXX
Company
KENTRON HEALTHCARE, INC.
Model
943384
Catalog number
943384
Device description
I.V. EXTENSION SET WITH KEN_SEF CONNECTOR 9" 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

Related Records

Contact Domains

Product Codes

CodeName
LHISet, I.V. Fluid Transfer

Product Code Classifications

CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00852244007044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00852244007044008522440070448522440070440852244007044

GMDN Terms

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

TypeValueUnit
Length9Inch

Sterilization Methods

Method

Contacts

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

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10810003751147KENOREX8044342024-04-14
10810003751154KENOREX8044362024-04-14
00810003754301KENTEX8264122024-03-02
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00810003754455KENTEX8264222024-03-02
00810003754486KENTEX8264242024-03-02

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