KENAFLEXX

GUDID 00810003753922

PADDED BOARD SPLINT 16" ORANGE

KENTRON HEALTHCARE, INC.

General-purpose medical foam padding, single-use General-purpose medical foam padding, single-use General-purpose medical foam padding, single-use General-purpose medical foam padding, single-use General-purpose medical foam padding, single-use General-purpose medical foam padding, single-use General-purpose medical foam padding, single-use General-purpose medical foam padding, single-use General-purpose medical foam padding, single-use General-purpose medical foam padding, single-use General-purpose medical foam padding, single-use General-purpose medical foam padding, single-use General-purpose medical foam padding, single-use

• Primary Device ID: 00810003753922
• NIH Device Record Key: 05381f7d-f332-48a2-b32b-4f3df4ddefcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KENAFLEXX
• Version Model Number: 885516
• Company DUNS: 618825723
• Company Name: KENTRON HEALTHCARE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810003753915 [Primary]
GS1	00810003753922 [Package]; Contains: 00810003753915; Package: CASE [50 Units]; In Commercial Distribution

FDA Product Code

• NOC: Splint, Extremity, Non-Inflatable, External, Non-Sterile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-27
• Device Publish Date: 2024-02-19

On-Brand Devices [KENAFLEXX]

• 10810003750140: IV ADMINISTRATION SET, 84", 60 DROPS/ML, KENTRON GRAVITO DIAL FLOW REGULATOR, 2 KEN_FLO Y SITES,
• 10810003750133: IV ADMINISTRATION SET, 86", 60 DROPS/ML, UNIVERSAL SPIKE, ROLLER CLAMP, 2 KEN_FLO LUER CONNECTOR
• 10810003750126: IV ADMINISTRATION SET, 84", 60 DROPS/ML, KENTRON GRAVITO FLOW REGULATOR, 2 KEN_SEF SPLIT SEPTUM
• 10810003750119: IV ADMINISTRATION SET, 84" LENGTH, 20 DROPS/ML,KENTRON GRAVITO DIAL FLOW CONTROLLER, 2 KEN_FLO Y
• 10810003750102: IV ADMINISTRATION SET, 84", 20 DROPS/ML, KENTRON GRAVITO DIAL FLOW CONTROLLER, 2 KEN_SEF SPLIT S
• 10810003750096: 12" IV EXTENSION SET WITH FEMALE LUER, KENTRON GRAVITO FLOW CONTROLLER, ONE KEN_FLO Y SITE, ONE
• 00810003750082: 12" IV EXTENSIO SET WITH FEMALE LUER CONNECTOR, KENTRON GRAVITO FLOW CONTROLLER, ONE KEN_FLO Y S
• 10810003750072: 12" IV EXTENSION SET WITH FEMALE LUER, KENTRON GRAVITO FLOW REGULATOR, ONE KEN_SEF SPLIT SEPTUM
• 10810003750065: IV ADMINISTRATION SET, 75", DRIP CHAMBER, FLOW REGULATOR, KEN_ROL MAME ROTATING LUER LOCK CONNEC
• 10810003750058: IV ADMINISTRATION SET, 78", VENTED SPIKE, DRIP CHAMBER, FLOW REGULATOR, 2 KEN_SEF SPLIT SEPTUM Y
• 10810003750041: IV ADMINISTRATION SET, 85", 15 DROPS/ML, VENTED SPIKE, DRIP CHAMBER, FLOW REGULATOR, KEN_ROL MAL
• 00810003750037: IV ADMINISTRATION SET, 92", VENTED SPIKE, DRIP CHAMBER, IN LINE FILTER, KEN_SEF SPLIT SEPTUM Y S
• 10810003750027: IV ADMINISTRATION SET, 92", 20 DROPS/ML, VENTED SPIKE, DRIP CHAMBER, KENTRON GRAVITO FLOW CONTRO
• 10810003750010: IV ADMINISTRATION SET, 100", 20 DROPS/ML, VENTED SPIKE, DRIP CHAMBER, IN LINE SOLUTION FILTER, O
• 10810003750003: IV ADMINISTRATION SET, 78", 15 DROPS/ML, ONE KEN_SEF SPLIT SEPTUM Y CONNECTOR, NON VENTED SPIKE,
• 00866512000293: NON INVASIVE BLOOD PRESSURE NYLON CUFF CHILD DOUBLE TUBE
• 00866512000286: NON INVASIVE BLOOD PRESSURE NYLON CUFF SMALL CHILD DOUBLE TUBE
• 00866512000279: NON INVASIVE BLOOD PRESSURE NYLON CUFF INFANT DOUBLE TUBE
• 00866512000262: NON INVASIVE BLOOD PRESSURE NYLON CUFF NEW BORN DOUBLE TUBE
• 00866512000255: NON INVASIVE BLOOD PRESSURE NYLON CUFF NEONATE #5 DOUBLE TUBE
• 10852244007881: 35" IV EXTENSION SET WITH FEMALE LUER AND ROTATING MALE LUER LOCK CONNECTOR AND THREE WAY STOP C
• 10852244007874: 20" IV EXTENSION SET WITH FEMALE LUER AND ROTATING MALE LUER LOCK, FLOW BCONTROLLER AND THREE WA
• 10852244007867: 6" EXTENSION SET WITH FEMALE LUER AND ROTATING MALE LUER LOCK CONNECTOR AND THREE WAY STOP COCK.
• 10852244007850: IV EXTENSION SET, 35" WITH FEMALE LUER CONNECTOR, KEN_ROL MALE ROTATING LUER LOCK CONNECTOR AND
• 10852244007843: IV EXTENSION SET WITH KEN_SEF SPLIT SEPTUN Y CONNECTOR, KEN_ROL MALE ROTATING LUER LOCK CENNECTO
• 10852244007836: 6" IV EXTENSION SET WITH FEMALE LUER CONNECTOR, KEN_ROL ROTATING MALE LUER LOCK CONNECTOR, FLOW
• 10852244007744: 8" I.V. EXTENSION SET WITH BONDED NEEDLELESS LUER CONNECTOR (KEN_FLO)
• 10852244007737: 6" I.V. EXTENSION SET WITH BONDED NEEDLELESS LUER CONNECTOR (KEN_FLO)
• 10852244007287: I.V. ADMINISTRATION SET 15 DROPS 96" WITH 2 KEN_FLO CONNECTORS
• 10852244007270: I.V. ADMINISTRATION SET 60 DROPS 76" WITH KEN_FLO CONNECTORS
• 10852244007263: I.V. ADMINISTRATION SET 10 DROPS 110" WITH 3 KEN_FLO CONNECTORS
• 10852244007256: I.V. ADMINISTRATION SET 10 DROPS 96" WITH 2 KEN_FLO CONNECTORS
• 10852244007249: I.V. ADMINISTRATION SET 60 DROPS WITH KEN_FLO AND KEN_SEF CONNECTORS
• 10852244007232: I.V. ADMINISTRATION SET 15 DROPS WITH KEN_FLO AND KEN_SEF CONNECTORS
• 10852244007225: I.V. ADMINISTRATION SET 10 DROPS WITH KEN_FLO AND KEN_SEF CONNECTORS
• 10852244007218: I.V. ADMINISTRATION SET 60 DROPS WITH 2 CONNECTORS AND 6" EXTENSION SET
• 10852244007201: I.V. ADMINISTRATION SET 15 DROPS WITH 2 CONNECTORS AND 6" EXTENSION SET
• 10852244007195: I.V. ADMINISTRATION SET 10 DROPS WITH 2 CONNECTORS AND 6" EXTENSION SET
• 10852244007188: I.V. ADMINISTRATION SET 60 DROPS WITH 2 KEN_SEF CONNECTORS
• 10852244007171: I.V. ADMINISTRATION SET 10 DROPS WITH 2 KEN_SEF CONNECTORS
• 10852244007164: I.V. ADMINISTRATION SET 60 DROPS WITH KEN_SEF AND LEVER LOCK CANNULA
• 10852244007157: I.V. ADMINISTRATION SET 10 DROPS WITH KEN_SEF AND LEVER LOCK CANNULA
• 10852244007140: KEN_FLO NEEDLE FREE CONNECTOR
• 10852244007133: I.V. EXTENSION SET WITH KEN_FLO CONNECTOR 6" LONG
• 10852244007126: I.V. EXTENSION SET WITH KEN_FLO AND KEN_SEF CONNECTORS 6" LONG
• 10852244007119: I.V. EXTENSION SET WITH KEN_FLO AND KEN_SEF CONNECTORS 10" LONG
• 10852244007102: I.V. EXTENSION SET WITH KEN_FLO AND KEN_SEF CONNECTORS 8" LONG
• 10852244007096: I.V. EXTENSION SET WITH KEN_SEF CONNECTOR 7.3" LONG
• 10852244007089: I.V. EXTENSION SET WITH KEN_SEF CONNECTOR 6.6" LONG
• 10852244007072: I.V. EXTENSION SET WITH KEN_SEF CONNECTOR 8" LONG