DEVICE: PEMCO INC (B15214500)

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Device Identifier (DI) Information

PEMCO INC
1450
1450
PEMCO INC
B15214500
HIBCC
1
Intracardiac Sucker Set with four Tips - Round, Adult Handle at 30 Degree Angle. Comes with Adult Tips 1450-05 10.5 mm diameter, 1450-06 8.8 mm diameter, 1450-07 8.0 mm diameter, 1450-08 6.4 mm diameter; can also use 1480-03 7.0 mm diameter tip. NOTE: All tips also fit 1480-04 sucker handle. Tips are grooved and slotted to allow for better flow and prevent clogging. Suckers have 3/8" & 1/2" barbed end. * Handles and tips may be ordered as separate items. .
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Suction cannula, reusable A rigid or semi-rigid, hand-held, metal or durable plastic tube designed as a conduit for the evacuation (suctioning) of blood, fluids, and other tissue debris directly from the surgical site during a surgical procedure (e.g., open-, plastic-, tissue/bone morcellation surgery). Also known as a suction tube, it is typically a general-purpose device to which the suction system tubing is connected proximally; some types may be attached to a dedicated handpiece that typically have a valve. Dedicated cannula specifically intended for a particular procedure (e.g., bronchial, dental, eye, uterine, oral, and liposuction) are also available. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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
Length: 10.5 Inch
Angle: 30 degree
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Device Status

In Commercial Distribution
September 19, 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)

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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

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12165242990
info@pemcomed.com
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