INNOVATE MEDICAL 10-1001-04

GUDID 00852937003018

Blood Culture Kit

INNOVATE MEDICAL, LLC

Blood culture broth kit IVD

• Primary Device ID: 00852937003018
• NIH Device Record Key: f410ca8f-fa58-4fab-9925-34a00394e39e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNOVATE MEDICAL
• Version Model Number: 10-1001-04
• Catalog Number: 10-1001-04
• Company DUNS: 050339980
• Company Name: INNOVATE MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true

Customer Support Contacts

• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com
• Phone: 4234613558
• Email: QA@innovatemed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852937003018 [Primary]
GS1	10852937003015 [Package]; Package: case [20 Units]; In Commercial Distribution

FDA Product Code

• OFM: Phlebotomy Blood Collection Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-22
• Device Publish Date: 2022-11-14

On-Brand Devices [INNOVATE MEDICAL]

• 10852937003305: Innovate Medical Esmark Bandage Blue 6x12
• 10852937003299: Innovate Medical Esmark Bandage Blue 6x9
• 10852937003282: Innovate Medical Esmark Bandage Blue 4x12
• 10852937003275: Innovate Medical Esmark Bandage Blue 4x9
• 10852937003060: Innovate Medical Esmark Bandage Blue 6x12
• 10852937003053: Innovate Medical Esmark Bandage Blue 6x9
• 10852937003046: Innovate Medical Esmark Bandage Blue 4x12
• 10852937003039: Innovate Medical Esmark Bandage Blue 4x9
• 10852937003022: Blood Culture Kit
• 00852937003018: Blood Culture Kit