Helmer

GUDID 00816394021664

Environmentatal chamber for storage of platelet concentrate

HELMER, INC.

Platelet incubator Platelet incubator Platelet incubator Platelet incubator Platelet incubator Platelet incubator Platelet incubator Platelet incubator Platelet incubator Platelet incubator Platelet incubator Platelet incubator Platelet incubator Platelet incubator Platelet incubator Platelet incubator 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.

• 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
• 00816394020964 - i.Series®: 2019-03-11 Platelet Incubator