FDA.reportPublic FDA data

i.Series®

Primary DI
00816394020780
Brand
i.Series®
Company
HELMER, INC.
Model
PC4200i
Device description
Platelet Incubator
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSHChamber, Environmental For The Storage Of Platelet Concentrate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSHChamber, Environmental For The Storage Of Platelet ConcentrateHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816394020780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816394020780008163940207808163940207800816394020780

GMDN Terms#

Term, Definition table
TermDefinition
Platelet incubatorAn electrically-powered device intended to be used to store and/or transport platelet concentrates while keeping them warm (typically from 20° to 24° Celsius). It is a cabinet-like chamber with shelves, and typically includes built-in temperature displays and an alarm triggered by out-of-range temperature variations; some types may in addition have built-in platelet agitators.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
317-773-9073techservice@helmerinc.com

Regulatory Flags#

DUNS number
086685682
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816394021855Helmer ScientificHPR118-GXC2026-05-13
00816394021916Helmer ScientificHBR118-GXC2026-05-13
00816394021923Helmer ScientificiBR118-GXC2026-05-13
00816394021930Helmer ScientificHLR118-GXC2026-05-13
00816394021947Helmer ScientificiLR118-GXC2026-05-13
00816394021954Helmer ScientificiPR118-GXC2026-05-13
00816394021961Helmer ScientificHBR120-GXC2026-05-13
00816394021978Helmer ScientificiBR120-GXC2026-05-13
00816394021985Helmer ScientificHLR120-GXC2026-05-13
00816394021992Helmer ScientificiLR120-GXC2026-05-13
00816394022005Helmer ScientificHPR120-GXC2026-05-13
00816394022012Helmer ScientificiPR120-GXC2026-05-13
00816394022036Helmer ScientificHBR125-GXC2026-05-13
00816394022043Helmer ScientificiBR125-GXC2026-05-13
00816394022050Helmer ScientificHLR125-GXC2026-05-13
00816394022067Helmer ScientificiLR125-GXC2026-05-13
00816394022074Helmer ScientificHPR125-GXC2026-05-13
00816394022081Helmer ScientificiPR125-GXC2026-05-13
00816394021824FarrarFCF1332025-01-10
00816394021640HelmeriUF126-GX2019-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00863626000294Boekel Floor Standing Platelet Incubator AgitatorBOEKEL INDUSTRIES, INC.KSH2023-06-08
00816394021664HelmerHELMER, INC.KSH2022-12-30
00816394021671HelmerHELMER, INC.KSH2022-12-01
00816394021688HelmerHELMER, INC.KSH2022-12-01
00816394020940HelmerHELMER, INC.KSH2019-02-08
00816394020957HelmerHELMER, INC.KSH2019-02-08
00816394020964HelmerHELMER, INC.KSH2019-02-08
00863626000232Boekel Small Platelet IncubatorBOEKEL INDUSTRIES, INC.KSH2016-09-01
00863626000249Boekel Large Platelet IncubatorBOEKEL INDUSTRIES, INC.KSH2016-09-01
00816394020674Horizon Series™ HELMER, INC.KSH2016-07-01
00816394020681Horizon Series™ HELMER, INC.KSH2016-07-01
00816394020698Horizon Series™ HELMER, INC.KSH2016-07-01
00816394020704Horizon Series™ HELMER, INC.KSH2016-07-01
00816394020711Horizon Series™ HELMER, INC.KSH2016-07-01
00816394020728Horizon Series™ HELMER, INC.KSH2016-07-01
00816394020735i.Series® HELMER, INC.KSH2016-07-01
00816394020742i.Series® HELMER, INC.KSH2016-07-01
00816394020759i.Series® HELMER, INC.KSH2016-07-01
00816394020766i.Series® HELMER, INC.KSH2016-07-01
00816394020773i.Series® HELMER, INC.KSH2016-07-01