Distender II Barostat

GUDID 00627843670872

Main Reservoir Unit 1300 mL

G&J Electronics Inc

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• Primary Device ID: 00627843670872
• NIH Device Record Key: c755a992-78d9-431f-8df6-31e74595070b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distender II Barostat
• Version Model Number: Main-1300
• Company DUNS: 203222252
• Company Name: G&J Electronics 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: false
• Serial Number: true
• 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
GS1	00627843670872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991288

FDA Product Code

• FFX: System, Gastrointestinal Motility (Electrical)

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: 2016-11-14

Devices Manufactured by G&J Electronics Inc

• 00627843670957 - Distender II Barostat: 2019-02-25 Protocol Plus Software version 10.3
• 00627843670872 - Distender II Barostat: 2018-07-06Main Reservoir Unit 1300 mL
• 00627843670872 - Distender II Barostat: 2018-07-06 Main Reservoir Unit 1300 mL
• 00627843670889 - Distender II Barostat: 2018-07-06 External Reservoir Unit 1300 mL
• 00627843670896 - Distender II Barostat: 2018-07-06 External Reservoir Unit 1300/120 mL
• 00627843670902 - Distender II Barostat: 2018-07-06 External Reservoir Unit 120 mL
• 00627843670919 - Distender II Barostat: 2018-07-06 Perception Panel
• 00627843670926 - Distender II Barostat: 2018-07-06 Deluxe Perception Panel
• 00627843670933 - Distender II Barostat: 2018-07-06 Keypad