i.Series®

GUDID 00816394020940

Platelet Incubator

HELMER, INC.

Blood plasma freezer

• Primary Device ID: 00816394020940
• NIH Device Record Key: c77be3c9-c052-457e-be74-92fd9d7708e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i.Series®
• Version Model Number: PC100-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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com
• Phone: 317-773-9073
• Email: techservice@helmerinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816394020940 [Primary]

FDA Product Code

• KSE: Refrigerator, Freezer, Blood Storage
• 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: 2019-03-11
• Device Publish Date: 2019-02-08

On-Brand Devices [i.Series®]

• 00816394021046: Blood Bank Refrigerator - Undercounter, 5 cu ft
• 00816394020926: BloodBank Compartmental Access Refrigerator, 20 Bin
• 00816394020919: BloodBank Compartmental Access Refrigerator, 80 Bin
• 00816394020896: Ultra-Low Freezer, 26 cu ft
• 00816394020889: Ultra-Low Freezer, 24 cu ft
• 00816394020872: Ultra-Low Freezer, 18 cu ft
• 00816394020865: Ultra-Low Freezer, 16 cu ft
• 00816394020834: Platelet Agitator
• 00816394020810: Platelet Agitator
• 00816394020803: Platelet Agitator
• 00816394020797: Platelet Agitator
• 00816394020780: Platelet Incubator
• 00816394020773: Platelet Incubator
• 00816394020766: Platelet Incubator
• 00816394020759: Platelet Incubator
• 00816394020742: Platelet Incubator
• 00816394020735: Platelet Incubator
• 00816394020599: -30°C Laboratory Freezer, 25 cu ft
• 00816394020582: -30°C Laboratory Freezer, 20 cu ft
• 00816394020575: -20°C / -30°C Laboratory Freezer - Undercounter, 5 cu ft
• 00816394020568: -20°C / -30°C Laboratory Freezer - Undercounter, 4 cu ft
• 00816394020513: -30°C Plasma Storage Freezer, 25 cu ft
• 00816394020506: -30°C Plasma Storage Freezer, 20 cu ft
• 00816394020490: -30°C Plasma Storage Freezer - Undercounter, 5 cu ft
• 00816394020483: -30°C Plasma Storage Freezer - Undercounter, 4 cu ft
• 00816394020407: Pharmacy/Laboratory Refrigerator - Pass-Thru, 58 cu ft
• 00816394020391: Pharmacy Refrigerator, 56 cu ft
• 00816394020384: Pharmacy Refrigerator, 45 cu ft
• 00816394020377: Pharmacy/Laboratory Refrigerator - Pass-Thru, 26.5 cu ft
• 00816394020360: Pharmacy Refrigerator, 25 cu ft
• 00816394020353: Pharmacy Refrigerator, 20 cu ft
• 00816394020346: Pharmacy Refrigerator, 11 cu ft
• 00816394020247: Laboratory Refrigerator, 56 cu ft
• 00816394020230: Laboratory Refrigerator, 45 cu ft
• 00816394020223: Laboratory Refrigerator, 25 cu ft
• 00816394020216: Laboratory Refrigerator, 20 cu ft
• 00816394020209: Laboratory Refrigerator, 11 cu ft
• 00816394020193: Laboratory/Pharmacy Refrigerator - Undercounter, 5 cu ft
• 00816394020186: Laboratory/Pharmacy Refrigerator - Undercounter, 4 cu ft
• 00816394020087: Blood Bank Refrigerator - Pass-Thru, 58 cu ft
• 00816394020070: Blood Bank Refrigerator, 56 cu ft
• 00816394020063: Blood Bank Refrigerator, 45 cu ft
• 00816394020056: Blood Bank Refrigerator - Pass-Thru, 26.5 cu ft
• 00816394020049: Blood Bank Refrigerator, 25 cu ft
• 00816394020032: Blood Bank Refrigerator, 20 cu ft
• 00816394020025: Blood Bank Refrigerator, 11 cu ft
• 00816394020018: Blood Bank Refrigerator - Undercounter, 5 cu ft
• 00816394020001: Blood Bank Refrigerator - Undercounter, 4 cu ft
• 00816394021640: Ultra-Low Freezer, 26 cu ft
• 00816394021633: Ultra-Low Freezer, 24 cu ft