UltraCW®II N/A

GUDID 00816394020933

Automated Cell Washing System

HELMER, INC.

Cell washer IVD
Primary Device ID00816394020933
NIH Device Record Key69efa694-e2f2-4305-b541-c6d1f248c9a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraCW®II
Version Model NumberUltraCW II
Catalog NumberN/A
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone317-7739073
Emailtechservice@helmerinc.com
Phone317-7739073
Emailtechservice@helmerinc.com
Phone317-7739073
Emailtechservice@helmerinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816394020933 [Primary]

FDA Product Code

KSNCentrifuge, Cell-Washing, Automated For Immuno-Hematology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-14
Device Publish Date2018-04-13

Devices Manufactured by HELMER, INC.

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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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