NURSE ASSIST

GUDID B150PT000142264

NURSE ASSIST, INC.

Device-irrigation sterile water

• Primary Device ID: B150PT000142264
• NIH Device Record Key: 644343b0-a12c-4bf1-a1d3-9e1723425c3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NURSE ASSIST
• Version Model Number: PT00014226
• Company DUNS: 869434464
• Company Name: NURSE ASSIST, INC.
• Device Count: 400
• 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: 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	B150PT000142260 [Unit of Use]
HIBCC	B150PT000142264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030813

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

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: 2016-10-14

On-Brand Devices [NURSE ASSIST]

• B150PT000142264: PT00014226
• B150PT000142244: PT00014224
• B15075040: 7504
• B15075030: 7503
• B15075024: 14 FR RED RUBBER CATHETER - BZK SWABSTICKS PROCEDURE
• B15075020: 14 FR RED RUBBER CATHETER - BZK SWABSTICKS PROCEDURE
• B15075014: 14 FR CLEAR PLASTIC CATHETER-BZK SWABSTICKS PROCEDURE
• B15075010: 14 FR CLEAR PLASTIC CATHETER-BZK SWABSTICKS PROCEDURE
• B15074024: 8 FR CATHETER IN PEEL POUCH
• B15074020: 8 FR CATHETER IN PEEL POUCH
• B15074014: 8 FR CATHETER IN PLASTIC WALLET
• B15074010: 8 FR CATHETER IN PLASTIC WALLET
• B15073050: 7305
• B15073040: 7304
• B15073030: 7303
• B15073024: 14 FR RED RUBBER CATHETER-PVP SWABSTICKS PROCEDURE
• B15073020: 14 FR RED RUBBER CATHETER-PVP SWABSTICKS PROCEDURE
• B15073014: 14 FR CLEAR PLASTIC CATHETER-PVP SWABSTICKS PROCEDURE
• B15073010: 14 FR CLEAR PLASTIC CATHETER-PVP SWABSTICKS PROCEDURE
• B15072040: 7204
• B15072030: 7203
• B15072024: 14 FR RED RUBBER CATHETER-FORCEPS PROCEDURE
• B15072020: 14 FR RED RUBBER CATHETER-FORCEPS PROCEDURE
• B15072014: 14 FR CLEAR PLASTIC CATHETER - FORCEPS PROCEDURE
• B15072010: 7201
• B15060244: 60ML PREFILLED SYRINGE
• B150578504: 5ML PREFILLED SYRINGE
• B150578494: 3ML PREFILLED SYRINGE
• B150523334: 30ML PREFILLED SYRINGE
• B150523324: 10ML PREFILLED SYRINGE
• B150516384: 10ML PREFILLED SYRINGE
• B150516174: 30ML PREFILLED SYRINGE
• B150372024: 14 FR RED RUBBER CATHETER-FORCEPS PROCEDURE
• B15027650: 2765
• B1501210BP4: 10ML IV FLUSH SYRINGE, BULK
• B1501210BP2: 10ML IV FLUSH SYRINGE, BULK
• B15012104: 10ML IV FLUSH SYRINGE
• B15012102: 10ML IV FLUSH SYRINGE
• B1501205BP4: 5ML IV FLUSH SYRINGE, BULK
• B1501205BP2: 5ML IV FLUSH SYRINGE, BULK
• B15012054: 5ML IV FLUSH SYRINGE
• B15012052: 5ML IV FLUSH SYRINGE
• B1501203BP4: 3ML IV FLUSH SYRINGE, BULK
• B1501203BP2: 3ML IV FLUSH SYRINGE, BULK
• B15012034: 3ML IV FLUSH SYRINGE
• B15012032: 3ML IV FLUSH SYRINGE
• B1501030A4: 30ML PREFILLED SYRINGE
• B15010304: 30ML PREFILLED SYRINGE
• B15010104: 10ML PREFILLED SYRINGE
• B15064927764: USP Sterile Water, 100 mL Bottle