DEVICE: Descending Thoracic Pack (00060756720230)
Device Identifier (DI) Information
Descending Thoracic Pack
BEQ-T 22800
Not in Commercial Distribution
701049506
DATASCOPE CORP.
BEQ-T 22800
Not in Commercial Distribution
701049506
DATASCOPE CORP.
BEQ-RF32 RotaFlow
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Cardiopulmonary bypass system tubing set | A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWE | Tubing, Pump, 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 |
---|
Storage Environment Temperature: between 10 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
7dc95531-fb40-47bf-aa1e-2bb5ece734e4
March 29, 2018
2
April 22, 2016
March 29, 2018
2
April 22, 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 |
---|---|
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
[?]
18886278383
cpsurgery@maquet.com
cpsurgery@maquet.com