AT1 Autotransfusion Set 9005104

GUDID 04052682000454

AT1 Autotransfusion Set is a disposable for CATS containing a washing chamber, tubing, waste bag and reinfusion bag.

Fresenius Kabi AG

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Primary Device ID04052682000454
NIH Device Record Key094cbb6c-2efe-428c-a4d7-81706d1a15b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAT1 Autotransfusion Set
Version Model Number9005104
Catalog Number9005104
Company DUNS315654579
Company NameFresenius Kabi AG
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com
Phone+31591355864
Emailwilma.hilhorst@fresenius-kabi.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104052682000447 [Primary]
GS104052682000454 [Package]
Contains: 04052682000447
Package: [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CACApparatus, Autotransfusion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-03
Device Publish Date2015-09-01

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