INNOVAC 15-500

GUDID 00857182006104

INNOVAC VACUUM HANDLE

INNOVATIVE MEDICAL TECHNOLOGIES, INC

Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD Capillary blood pump IVD

• Primary Device ID: 00857182006104
• NIH Device Record Key: f005731e-26ac-49a8-bdeb-afcba7c5e36a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNOVAC
• Version Model Number: 15-500
• Catalog Number: 15-500
• Company DUNS: 792740578
• Company Name: INNOVATIVE MEDICAL TECHNOLOGIES, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com
• Phone: 866-560-1825
• Email: support@innovativemedtech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857182006104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972969

FDA Product Code

• JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

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: 2018-08-09
• Device Publish Date: 2016-09-14

Devices Manufactured by INNOVATIVE MEDICAL TECHNOLOGIES, INC

• 20857182006009 - INNOSET: 2019-10-23 SAFETY BLOOD COLLECTION SET 21G
• 10857182006019 - INNOSET: 2019-10-23 SAFETY BLOOD COLLECTION SET 23G
• 20857182006023 - INNOSET: 2019-10-23 SAFETY BLOOD COLLECTION SET 25G
• 30857182006006 - ULTRAGLIDE: 2019-10-23 SAFETY BLOOD COLLECTION SET 21G
• 30857182006013 - ULTRAGLIDE: 2019-10-23 SAFETY BLOOD COLLECTION SET 23G
• 30857182006020 - ULTRAGLIDE: 2019-10-23 SAFETY BLOOD COLLECTION SET 25G
• 60857182006007 - ULTRAFLO: 2019-10-23 SAFETY BLOOD COLLECTION SET 21G
• 60857182006014 - ULTRAFLO: 2019-10-23 SAFETY BLOOD COLLECTION SET 23G