DEVICE: Thoratec® VAD, Hand Pumping Bulb (00813024013136)

Device Identifier (DI) Information

Thoratec® VAD, Hand Pumping Bulb
14787-2589-000
In Commercial Distribution
14787-2589-000
Thoratec Corporation
00813024013136
GS1

1
070156955 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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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?
37883 General positive-pressure manual hand inflator
A hand-operated manual device designed to draw in ambient air and expel the air from a connected nozzle to inflate a device (e.g., mattress, patient head support rings); it is not intended to be used with invasive devices. It is typically designed as a bicycle pump, a stirrup pump, or a large syringe-like pump, and is designed for use in the home and healthcare facilities. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DSQ Ventricular (Assisst) Bypass
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 20 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

bf3487df-4d71-4688-81a4-ec7f724f2dcc
September 19, 2024
7
September 20, 2014
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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