MCKESSON

GUDID B150372340

NURSE ASSIST, INC.

Urological irrigation kit

• Primary Device ID: B150372340
• NIH Device Record Key: b8e89aa6-7a89-49ac-9d94-43a038ccf28b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MCKESSON
• Version Model Number: 37-234
• 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: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B150372340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K813027

FDA Product Code

• KYZ: Syringe, Irrigating (Non Dental)

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: 2018-07-06
• Device Publish Date: 2017-08-14

On-Brand Devices [MCKESSON]

• B150372340: 37-234
• B150372324: 14 FR RED RUBBER CATHETER-PVP SWABSTICKS PROCEDURE
• B150372320: 14 FR RED RUBBER CATHETER-PVP SWABSTICKS PROCEDURE
• B150372314: 14 FR CLEAR PLASTIC CATHETER-PVP SWABSTICKS PROCEDURE
• B150372310: 14 FR CLEAR PLASTIC CATHETER-PVP SWABSTICKS PROCEDURE
• B150372020: 14 FR RED RUBBER CATHETER-FORCEPS PROCEDURE