Dale Catheter Securement Device 850

GUDID 00817612020131

Dale IV, Arterial and Mid-line Catheter Securement Device

DALE MEDICAL PRODUCTS, INC.

Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder

• Primary Device ID: 00817612020131
• NIH Device Record Key: 80ea423d-ea79-44f9-817e-2a025f1e900d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dale Catheter Securement Device
• Version Model Number: 850
• Catalog Number: 850
• Company DUNS: 001061233
• Company Name: DALE MEDICAL PRODUCTS, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817612020124 [Primary]
GS1	00817612020131 [Package]; Contains: 00817612020124; Package: Box [50 Units]; In Commercial Distribution

FDA Product Code

• KMK: Device, Intravascular Catheter Securement

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-22
• Device Publish Date: 2018-09-10

On-Brand Devices [Dale Catheter Securement Device]

• 00817612020933: Dale IV Art& M-Line Catheter Securement Device Kit
• 00817612020919: Dale IV, Arterial and Mid-line Catheter Securement Device Kit
• 00817612020193: Dale CVC, PICC and Arterial Sheath Catheter Securement Device Kit
• 00817612020179: Dale CVC, PICC and Arterial Sheath Catheter Securement Device
• 00817612020155: Dale IV Start Kit
• 00817612020131: Dale IV, Arterial and Mid-line Catheter Securement Device
• 00817612020032: Dale CVC, PICC and Arterial Sheath Catheter Securement Device Kit