DEVICE: PEMCO INC (B15214600)

Device Identifier (DI) Information

PEMCO INC
1460
In Commercial Distribution
1460
PEMCO INC
B15214600
HIBCC

1
004217071 *Terms of Use
Intracardiac Sucker: Flat, Pediatric Handle Fixed Tip, 3.2 mm diameter. Handle is 7.5 inches long with a 30 Degree Angle. Tips are grooved and slotted to allow for better flow and prevent clogging. Suckers have 5/16" barbed end. Alternate tip and handle styles are available.
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Device Characteristics

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

GMDN

[?]

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

[?]
Product Code Product Code Name
DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
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FDA Premarket Submission

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

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
Angle: 30 degree
Length: 7.5 Inch
Outer Diameter: 3.2 Millimeter
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Device Record Status

b4b3a945-d7eb-4bcd-b99a-5965de886aaf
March 29, 2018
2
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)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
12165242990
info@pemcomed.com
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