DEVICE: AngioJet® Ultra 5000A (08714729890607)

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Device Record History
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Device Identifier (DI) Information
AngioJet® Ultra 5000A
105650-001R
In Commercial Distribution
105650
BOSTON SCIENTIFIC CORPORATION
08714729890607
GS1

1
021717889 *Terms of Use
Console
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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?
36777 General-purpose suction system, line-powered
An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of settings within healthcare facilities.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
MCX CATHETER, CORONARY, ATHERECTOMY
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P980037 014
P980037 027
P980037 030
P980037 034
P980037 036
P980037 038
P980037 045
P980037 050
P980037 057
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
5a5b22c8-d491-4156-ab05-b8d276e2e6e7
July 06, 2018
3
April 21, 2015
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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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