KATENA

GUDID B150K870650

NURSE ASSIST, INC.

Electrical-only medical device connection cable, reusable

• Primary Device ID: B150K870650
• NIH Device Record Key: 8486fdda-14ca-40b7-8b34-9fd3a67d75e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KATENA
• Version Model Number: K8-7065
• Company DUNS: 869434464
• Company Name: NURSE ASSIST, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B150K870650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942194

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-14

Devices Manufactured by NURSE ASSIST, INC.

• 10850421008928 - NURSE ASSIST: 2024-07-18 0.9% Sodium Chloride IV Flush Syringe for Sterile Delivery, 10mL Fill, 1210-SF, Syringe/Pouch
• 00850421008198 - SteriCare Solutions: 2024-02-16 USP Normal Saline, 500 mL Bottle
• 00850421008891 - SteriCare Solutions: 2024-02-16 500 ML, USP STERILE WATER, BOTTLE
• B15064927750 - SteriCare Solutions: 2024-02-16 USP Normal Saline, 100 mL Bottle
• B15064927764 - Nurse Assist: 2024-02-16 USP Sterile Water, 100 mL Bottle
• 00850421008747 - SteriCare Solutions: 2022-11-28 USP Normal Saline, Wound Flush, 7 oz
• 00850421008754 - SteriCare Solutions: 2022-11-28 USP Normal Saline, Would Flush, 3 oz
• 00850421008839 - SteriCare Solutions: 2022-11-28 USP Normal Saline, 500 mL Bottle