Springfusor SF10-28

GUDID 09350902000365

GO MEDICAL INDUSTRIES PTY. LTD.

Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable

• Primary Device ID: 09350902000365
• NIH Device Record Key: 9572581c-6e68-43bf-a436-6e95dc5d1182
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Springfusor
• Version Model Number: Springfusor 10
• Catalog Number: SF10-28
• 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: false
• 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	09350902000341 [Primary]
GS1	09350902000358 [Package]; Contains: 09350902000341; Package: Carton [5 Units]; In Commercial Distribution
GS1	09350902000365 [Package]; Contains: 09350902000341; Package: Shipping carton [150 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910007

FDA Product Code

• FRN: Pump, Infusion

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: 2022-06-17
• Device Publish Date: 2017-05-17

On-Brand Devices [Springfusor]

• 09350902001683: Springfusor 50/60
• 09350902000389: Springfusor 30
• 09350902000365: Springfusor 10