Helmer

GUDID 00816394021664

Environmentatal chamber for storage of platelet concentrate

HELMER, INC.

Platelet incubator

• Primary Device ID: 00816394021664
• NIH Device Record Key: f6461b7f-b741-49e1-8340-6bc2590a4b42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Helmer
• Version Model Number: PC4200-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	00816394021664 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-05-09
• Device Publish Date: 2022-12-30

Devices Manufactured by HELMER, INC.

• 00816394021824 - Farrar: 2025-01-20 Ultralow temperature freezer
• 00816394021664 - Helmer: 2024-05-09Environmentatal chamber for storage of platelet concentrate
• 00816394021664 - Helmer: 2024-05-09 Environmentatal chamber for storage of platelet concentrate
• 00816394021695 - i.Series®: 2023-10-16 Blood Bank Compartmental Access Refrigerator 20 Bin
• 00816394021770 - i.Series®: 2023-10-10 Blood Bank Compartmental Access Refrigerator 80 Bin
• 00816394021671 - i.Series Platelet Incubator: 2022-12-09 Environmentatal chamber for storage of platelet concentrate
• 00816394021688 - i.Series Platelet Incubator: 2022-12-09 Environmentatal chamber for storage of platelet concentrate
• 00816394020940 - i.Series®: 2019-03-11 Platelet Incubator
• 00816394020957 - i.Series®: 2019-03-11 Platelet Incubator