Kit Rinse Manifold, Packaged 00000011857

GUDID 08430793057080

Bulk ACL TOP System Rinse Manifold

INSTRUMENTATION LABORATORY COMPANY

Wash/cleaning solution IVD, automated/semi-automated system
Primary Device ID08430793057080
NIH Device Record Keyeae5a7c3-a8a7-4890-be0e-7f42a84afb87
Commercial Distribution StatusIn Commercial Distribution
Brand NameKit Rinse Manifold, Packaged
Version Model Number00000011857
Catalog Number00000011857
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-678-0710
Emailtechsupport@ilww.com
Phone800-678-0710
Emailtechsupport@ilww.com
Phone800-678-0710
Emailtechsupport@ilww.com
Phone800-678-0710
Emailtechsupport@ilww.com
Phone800-678-0710
Emailtechsupport@ilww.com
Phone800-678-0710
Emailtechsupport@ilww.com
Phone800-678-0710
Emailtechsupport@ilww.com
Phone800-678-0710
Emailtechsupport@ilww.com
Phone800-678-0710
Emailtechsupport@ilww.com
Phone800-678-0710
Emailtechsupport@ilww.com
Phone800-678-0710
Emailtechsupport@ilww.com
Phone800-678-0710
Emailtechsupport@ilww.com
Phone800-678-0710
Emailtechsupport@ilww.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108430793057080 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-01
Device Publish Date2020-06-23

Devices Manufactured by INSTRUMENTATION LABORATORY COMPANY

08430793242998 - HEMOSIL RIVAROXABAN CONTROLS2024-07-30 1. Rivaroxaban Low Control (Cat. No. 0020015510): 5 x 1mL vials 2. Rivaroxaban High Control (Cat. No. 0020015520): 5 x 1mL vial
08430793243001 - HEMOSIL RIVAROXABAN CALIBRATORS2024-07-30 1. Rivaroxaban Calibrator 1 (Cat. No. 0020015410): 5 x 1mL vials 2. Rivaroxaban Calibrator 2 (Cat. No. 0020015420) : 5 x 1mL vi
00195226001129 - HemosIL Chromogenic Factor IX2024-07-17 HemosIL Chromogenic Factor IX
00195226000528 - ACL TOP 7702024-05-23 ACL TOP 770
00195226000535 - ACL TOP 770 LAS2024-05-23 ACL TOP 770 LAS
00195226000542 - ACL TOP 770s2024-05-23 ACL TOP 770s
00195226000559 - ACL TOP 5702024-05-23 ACL TOP 570
00195226000566 - ACL TOP 3702024-05-23 ACL TOP 370

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