Precision Disposable Products

GUDID 00865773000332

ECG Electrodes Case - Square

PRECISION DISPOSABLE PRODUCTS INC

Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit Nitrogen terminal unit

• Primary Device ID: 00865773000332
• NIH Device Record Key: e60e4289-5728-4a1b-bcfa-a3fa5716ee74
• 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: 2000
• 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	00865773000332 [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