HCT

GUDID 00852937003070

INNOVATE MEDICAL, LLC

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• Primary Device ID: 00852937003070
• NIH Device Record Key: 56b06106-90f8-45b6-9fb1-28376db48a14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HCT
• Version Model Number: HCTBBD-100
• Company DUNS: 050339980
• Company Name: INNOVATE MEDICAL, LLC
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903083411 [Unit of Use]
GS1	00852937003070 [Primary]
GS1	10852937003077 [Package]; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• KYW: Container, Liquid Medication, Graduated

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-16
• Device Publish Date: 2023-08-08

On-Brand Devices [HCT]

• 00852937003087: HCT9849-1
• 00852937003070: HCTBBD-100