DEVICE: PEMCO INC (B1521450060)
Device Identifier (DI) Information
PEMCO INC
1450-06
In Commercial Distribution
1450-06
PEMCO INC
1450-06
In Commercial Distribution
1450-06
PEMCO INC
Adult Intracardiac Sucker Tip - 8.8 mm diameter. Tips are grooved and slotted to allow for better flow and prevent clogging.
For use with the Round Adult Handle 30 Degree Angle (1450-01), the Round Adult Handle 90 Degree Angle (1450-01-90) OR the Flat Adult Handle (1480-04)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
45254 | 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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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 8.8 Millimeter |
Device Record Status
cda6c350-97ba-44e3-9491-ad4e56fd2c10
March 29, 2018
2
September 19, 2016
March 29, 2018
2
September 19, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
12165242990
info@pemcomed.com
info@pemcomed.com