Precision Disposable Products

GUDID 00865773000349

ECG Electrodes Case - Square

PRECISION DISPOSABLE PRODUCTS INC

Nitrogen terminal unit

• Primary Device ID: 00865773000349
• NIH Device Record Key: bcf0aa89-79a7-46f4-a7f9-22b6491cabb1
• Commercial Distribution Discontinuation: 2019-01-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Precision Disposable Products
• Version Model Number: SF22
• Company DUNS: 080389387
• Company Name: PRECISION DISPOSABLE PRODUCTS INC
• Device Count: 50
• 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: true
• 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
GS1	00865773000349 [Primary]
GS1	00865773000356 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041954

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-06-23
• Device Publish Date: 2016-11-16

On-Brand Devices [Precision Disposable Products]

• 00865773000370: ECG Electrodes Case - Teardrop
• 00865773000363: ECG Electrodes Case - Teardrop
• 00865773000349: ECG Electrodes Case - Square
• 00865773000332: ECG Electrodes Case - Square
• 00865773000318: ECG Electrodes Bag - Circle
• 00865773000301: ECG Electrodes Case - Circle