Patient Controlled Epidural Analgesia Device (PCEA) PCIEPRE15

GUDID 09350902000334

GO MEDICAL INDUSTRIES PTY. LTD.

Ambulatory non-insulin infusion pump, mechanical, single-use Ambulatory non-insulin infusion pump, mechanical, single-use Ambulatory non-insulin infusion pump, mechanical, single-use Ambulatory non-insulin infusion pump, mechanical, single-use Ambulatory non-insulin infusion pump, mechanical, single-use

• Primary Device ID: 09350902000334
• NIH Device Record Key: b2f4ac28-dfca-4c5c-b0bc-f13b028a0495
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Controlled Epidural Analgesia Device (PCEA)
• Version Model Number: PCEA
• Catalog Number: PCIEPRE15
• Company DUNS: 757634266
• Company Name: GO MEDICAL INDUSTRIES PTY. LTD.
• 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: 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
GS1	09350902000310 [Primary]
GS1	09350902000327 [Package]; Contains: 09350902000310; Package: Carton [5 Units]; In Commercial Distribution
GS1	09350902000334 [Package]; Contains: 09350902000310; Package: Shipping carton [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972158

FDA Product Code

• MEB: Pump, Infusion, Elastomeric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-17
• Device Publish Date: 2017-05-18

Devices Manufactured by GO MEDICAL INDUSTRIES PTY. LTD.

• 9350902000419 - Flow Control Tubing: 2024-04-03
• 9350902000440 - Flow Control Tubing: 2024-04-03
• 9350902000471 - Flow Control Tubing: 2024-04-03
• 9350902000501 - Flow Control Tubing: 2024-04-03
• 9350902000532 - Flow Control Tubing: 2024-04-03
• 9350902000563 - Flow Control Tubing: 2024-04-03
• 9350902000594 - Flow Control Tubing: 2024-04-03
• 9350902000624 - Flow Control Tubing: 2024-04-03