Helmer

GUDID 00816394021664

Environmentatal chamber for storage of platelet concentrate

HELMER, INC.

Platelet incubator
Primary Device ID00816394021664
NIH Device Record Keyf6461b7f-b741-49e1-8340-6bc2590a4b42
Commercial Distribution StatusIn Commercial Distribution
Brand NameHelmer
Version Model NumberPC4200-Pro
Company DUNS086685682
Company NameHELMER, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816394021664 [Primary]

FDA Product Code

KSHChamber, Environmental For The Storage Of Platelet Concentrate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-05-09
Device Publish Date2022-12-30

Devices Manufactured by HELMER, INC.

00816394021664 - Helmer2024-05-09Environmentatal chamber for storage of platelet concentrate
00816394021664 - Helmer2024-05-09 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 Incubator2022-12-09 Environmentatal chamber for storage of platelet concentrate
00816394021688 - i.Series Platelet Incubator2022-12-09 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

Trademark Results [Helmer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HELMER
HELMER
86103845 4559456 Live/Registered
NINGBO WELAND IMP & EXP CO., LTD.
2013-10-29
HELMER
HELMER
77625775 3668805 Live/Registered
Helmer Inc.
2008-12-03

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