HAEMONETICS CARDIOPAT

GUDID 30812747017941

CARDIOPAT, US LN 02050-US

HAEMONETICS CORPORATION

Blood-processing autotransfusion system Blood-processing autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Red blood cell-recovery autotransfusion system Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump Autotransfusion system blood collection/processing pump
Primary Device ID30812747017941
NIH Device Record Key267a469a-3877-424f-bd47-f5f8aa66c8ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAEMONETICS CARDIOPAT
Version Model Number02050-US
Company DUNS057827420
Company NameHAEMONETICS CORPORATION
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com
Phone800-537-2802
Emailproductsupport@haemonetics.com

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS130812747017941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CACApparatus, Autotransfusion

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 Date2015-10-20

On-Brand Devices [HAEMONETICS CARDIOPAT]

30812747017941CARDIOPAT, US LN 02050-US
30812747017279CARDIOPAT, US LN 02050-US

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