Horizon Series™

GUDID 00816394020254

Laboratory/Pharmacy Refrigerator - Undercounter, 4 cu ft

HELMER, INC.

Blood refrigerator

• Primary Device ID: 00816394020254
• NIH Device Record Key: e642700b-72ee-4ec9-961d-9a3d29d2e2b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Horizon Series™
• Version Model Number: HLR104-ADA
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816394020254 [Primary]

FDA Product Code

• KSE: Refrigerator, Freezer, Blood Storage

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-26
• Device Publish Date: 2016-07-01

On-Brand Devices [Horizon Series™ ]

• 00816394020858: Platelet Agitator
• 00816394020841: Platelet Agitator
• 00816394020827: Platelet Agitator
• 00816394020728: Platelet Incubator
• 00816394020711: Platelet Incubator
• 00816394020704: Platelet Incubator
• 00816394020698: Platelet Incubator
• 00816394020681: Platelet Incubator
• 00816394020674: Platelet Incubator
• 00816394020636: -30°C Laboratory Freezer, 25 cu ft
• 00816394020629: -30°C Laboratory Freezer, 20 cu ft
• 00816394020612: -20°C / -30°C Laboratory Freezer - Undercounter, 5 cu ft
• 00816394020605: -20°C / -30°C Laboratory Freezer - Undercounter, 4 cu ft
• 00816394020551: -30°C Plasma Storage Freezer, 25 cu ft
• 00816394020544: -30°C Plasma Storage Freezer, 20 cu ft
• 00816394020537: -30°C Plasma Storage Freezer - Undercounter, 5 cu ft
• 00816394020520: -30°C Plasma Storage Freezer - Undercounter, 4 cu ft
• 00816394020476: Pharmacy/Laboratory Refrigerator - Pass-Thru, 58 cu ft
• 00816394020469: Pharmacy Refrigerator, 56 cu ft
• 00816394020452: Pharmacy Refrigerator, 45 cu ft
• 00816394020445: Pharmacy/Laboratory Refrigerator - Pass-Thru, 26.5 cu ft
• 00816394020438: Pharmacy Refrigerator, 25 cu ft
• 00816394020421: Pharmacy Refrigerator, 20 cu ft
• 00816394020414: Pharmacy Refrigerator, 11 cu ft
• 00816394020315: Laboratory Refrigerator, 56 cu ft
• 00816394020308: Laboratory Refrigerator, 45 cu ft
• 00816394020292: Laboratory Refrigerator, 25 cu ft
• 00816394020285: Laboratory Refrigerator, 20 cu ft
• 00816394020278: Laboratory Refrigerator, 11 cu ft
• 00816394020261: Laboratory/Pharmacy Refrigerator - Undercounter, 5 cu ft
• 00816394020254: Laboratory/Pharmacy Refrigerator - Undercounter, 4 cu ft
• 00816394020179: Blood Bank Refrigerator - Pass-Thru, 58 cu ft
• 00816394020162: Blood Bank Refrigerator, 56 cu ft
• 00816394020155: Blood Bank Refrigerator, 45 cu ft
• 00816394020148: Blood Bank Refrigerator - Pass-Thru, 26.5 cu ft
• 00816394020131: Blood Bank Refrigerator, 25 cu ft
• 00816394020124: Blood Bank Refrigerator, 20 cu ft
• 00816394020117: Blood Bank Refrigerator, 11 cu ft
• 00816394020100: Blood Bank Refrigerator - Undercounter, 5 cu ft
• 00816394020094: Blood Bank Refrigerator - Undercounter, 4 cu ft
• 00816394021602: -30°C Blood Bank Freezer, 25 cu ft
• 00816394021589: -30°C Blood Bank Freezer, 20 cu ft
• 00816394021565: -30°C Blood Bank Freezer - Undercounter, 5 cu ft
• 00816394021541: -30°C Laboratory Freezer, 25 cu ft
• 00816394021527: -30°C Laboratory Freezer, 20 cu ft
• 00816394021503: -20°C / -30°C Laboratory Freezer - Undercounter, 5 cu ft
• 00816394021480: Pharmacy Refrigerator - Pass-Thru, 58 cu ft
• 00816394021466: Pharmacy Refrigerator - Pass-Thru, 26.5 cu ft
• 00816394021435: Blood Bank Refrigerator - Pass-Thru, 58 cu ft
• 00816394021411: Blood Bank Refrigerator - Pass-Thru, 26.5 cu ft