i.Series Platelet Incubator

GUDID 00816394021688

Environmentatal chamber for storage of platelet concentrate

HELMER, INC.

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• Primary Device ID: 00816394021688
• NIH Device Record Key: 10fb54a7-883e-4e6d-8f2c-46e68937dc74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i.Series Platelet Incubator
• Version Model Number: PC2200-Pro
• Company DUNS: 086685682
• Company Name: HELMER, INC.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816394021688 [Primary]

FDA Product Code

• KSH: Chamber, Environmental For The Storage Of Platelet Concentrate

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: 2022-12-09
• Device Publish Date: 2022-12-01

On-Brand Devices [i.Series Platelet Incubator]

• 00816394021688: Environmentatal chamber for storage of platelet concentrate
• 00816394021671: Environmentatal chamber for storage of platelet concentrate