UltraCW®

GUDID 00816394020902

Automatic Cell Washing System

HELMER, INC.

Cell washer IVD
Primary Device ID00816394020902
NIH Device Record Keyd2e711c3-4b91-456b-b763-ed8e5f80e62e
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraCW®
Version Model NumberUltraCW
Company DUNS086685682
Company NameHELMER, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone317-773-9073
Emailtechservice@helmerinc.com
Phone317-773-9073
Emailtechservice@helmerinc.com
Phone317-773-9073
Emailtechservice@helmerinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816394020902 [Primary]

FDA Product Code

KSNCentrifuge, Cell-Washing, Automated For Immuno-Hematology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-07-01

Devices Manufactured by HELMER, INC.

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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 [UltraCW]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ULTRACW
ULTRACW
78197386 2852009 Live/Registered
HELMER, INC.
2002-12-23

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