FDA.reportPublic FDA data

i.Series®

Primary DI
00816394020797
Brand
i.Series®
Company
HELMER, INC.
Model
PF15i
Device description
Platelet Agitator
Published
2016-07-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSQDevice, Blood Mixing And Blood Weighing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSQDevice, Blood Mixing And Blood WeighingHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816394020797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816394020797008163940207978163940207970816394020797

GMDN Terms#

Term, Definition table
TermDefinition
Platelet agitatorA mains electricity (AC-powered), electromechanical device typically used by blood bank and transfusion services to provide gentle agitation (e.g., side-to-side motion) required for platelet storage. The device will typically provide several drawers on which to place containers of platelets. It may include an audible alarm that sounds if agitation does not occur during use.

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
00866305000288Genesis Tube StripperGENESIS BPS LLCKSQ2025-01-31
04086000860888COMPOGUARD Advance BasicFresenius Kabi AGKSQ2024-10-30
04086000860895COMPOGUARD Advance DataFresenius Kabi AGKSQ2024-10-29
04086000860901COMPOGUARD Advance COMPLETEFresenius Kabi AGKSQ2024-10-29
00850047037077HemoFlowApplied Science, Inc.KSQ2024-03-11
00850047037084HemoFlowApplied Science, Inc.KSQ2024-03-11
00850047037053HemoFlowApplied Science, Inc.KSQ2023-09-08
00863626000270Boekel Blood Collection MixerBOEKEL INDUSTRIES, INC.KSQ2023-06-08
00850047037022HemoFlowApplied Science, Inc.KSQ2023-03-14
00850047037039HemoFlowApplied Science, Inc.KSQ2023-03-03
00850047037046HemoFlowApplied Science, Inc.KSQ2023-03-03
00850047037008HemoFlowApplied Science, Inc.KSQ2023-02-21
00850047037015HemoFlowApplied Science, Inc.KSQ2023-02-21
04038917141154Tube- Stripper AST-2Sarstedt Aktiengesellschaft & Co.KGKSQ2022-11-30
04038917258869Tube-Stripper AST-2SSarstedt Aktiengesellschaft & Co.KGKSQ2022-11-30
04086000860741CompoGuard Basic (NA)Fresenius Kabi AGKSQ2022-11-10
04086000860758CompoGuard Data (NA)Fresenius Kabi AGKSQ2022-11-10
04086000860765CompoGuard Complete (NA)Fresenius Kabi AGKSQ2022-11-10
00810020440065Donor Tube StripperFresenius Kabi AGKSQ2022-11-04
00810020440348Fresenius Kabi Adjustable Automatic Donor Scale Support StandFresenius Kabi AGKSQ2021-08-18
10810020440345Fresenius Kabi Adjustable Automatic Donor Scale Support StandFresenius Kabi AGKSQ2021-08-18
04028339620139TRANSWAAGTransmed Medizintechnik GmbH & Co. KGKSQ2020-09-01
08809241446224Blood Collection Monitor CM350CENTRON CORPORATIONKSQ2020-04-17
08809241446132Blood Collection Mixer CM735ACENTRON CORPORATIONKSQ2020-04-03
08809241446446Data Collection Mixer DCM3000 (BASIC)CENTRON CORPORATIONKSQ2020-04-03
00863626000218Boekel Small Platelet AgitatorBOEKEL INDUSTRIES, INC.KSQ2019-05-16
00816394020971HelmerHELMER, INC.KSQ2019-02-08
00816394020988HelmerHELMER, INC.KSQ2019-02-08
00816394020995HelmerHELMER, INC.KSQ2019-02-08
00863626000225Boekel Large Platelet AgitatorBOEKEL INDUSTRIES, INC.KSQ2017-01-31