ROTEM® 503-10-US

GUDID 04260160470099

The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to pro

Tem Innovations GmbH

Multiple coagulation factor IVD, reagent
Primary Device ID04260160470099
NIH Device Record Key27b853b4-9363-4006-96a8-6984a5a0d86b
Commercial Distribution StatusIn Commercial Distribution
Brand NameROTEM®
Version Model Numberstar-tem® 20
Catalog Number503-10-US
Company DUNS506692297
Company NameTem Innovations GmbH
Device Count10
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104260160470099 [Primary]
GS104260160470518 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGNPlasma, Coagulation Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [ROTEM®]

04260160470587The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
04260160470242The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation
04260160470112ROTROL P is a quality control material for monitoring accuracy and precision of tests carried ou
04260160470105ROTROL N is a quality control material for monitoring accuracy and precision of tests carried ou
04260160470099The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
04260160470082The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
04260160470075The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboel
04260160470068The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboela
04260160470044The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
04260160470020The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
04260160470372The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use i
04260160470624The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use i
04260160470617The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use i
04260160470600The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use i

Trademark Results [ROTEM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ROTEM
ROTEM
87758345 not registered Live/Pending
Stark Aerospace, Inc.
2018-01-17
ROTEM
ROTEM
79140675 4650940 Live/Registered
C A Casyso GmbH
2013-08-28
ROTEM
ROTEM
79130225 not registered Indifferent
C A Casyso AG; c/o Caspar Stürm
2013-01-22
ROTEM
ROTEM
78705253 3271664 Live/Registered
MUNTERS ISRAEL LTD.
2005-09-01
ROTEM
ROTEM
76511677 2868719 Dead/Cancelled
CA CASYSO AG
2003-05-05
ROTEM
ROTEM
73594377 1429980 Dead/Cancelled
ROTEM INTERNATIONAL AGRICULTURAL SYSTEMS (1985) LTD.
1986-04-21

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