DEVICE: CircuCool™ 8005 Pump (08714729454816)

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Device Record History
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Device Identifier (DI) Information
CircuCool™ 8005 Pump
M0048005R0
Not in Commercial Distribution

BOSTON SCIENTIFIC CORPORATION
08714729454816
GS1
December 16, 2020
1
021717889 *Terms of Use
Model 8005 Pump
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36664 Basic roller pump
A mains electricity (AC-powered) pump using rotating rollers which squeeze a soft-walled tubing against the housing wall, thus producing a pulsatile pumping effect. It is typically used for the delivery of precise quantities of liquids (e.g., for laboratory devices and equipment). For the roller pump used in open heart surgery see the appropriate GMDN code.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LPB Cardiac ablation percutaneous catheter
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P980003 000
P980003 001
P980003 002
P980003 004
P980003 005
P980003 007
P980003 008
P980003 009
P980003 010
P980003 013
P980003 015
P980003 016
P980003 018
P980003 019
P980003 021
P980003 024
P980003 025
P980003 027
P980003 028
P980003 030
P980003 031
P980003 034
P980003 038
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
e9ccaf85-4772-471f-af46-fed22b6a6acf
July 11, 2024
4
August 08, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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