DEVICE: Rocket (05055270900067)

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Device Identifier (DI) Information

Rocket
R54410-16-17
R54410-16-17
ROCKET MEDICAL PLC
05055270900067
GS1
1
Rocket IPC Split Dilator 16G x 17cm
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Device Characteristics

MR Safe
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
Pleural drainage system fluid collector A sterile device that is a component of a pleural drainage system and used for the collection of abnormal fluid accumulation (e.g., effusions) from the pleural cavity. It has an integral three-chambered construction; these are the drainage chamber, the suction control chamber and a water seal (underwater) chamber. It is connected to the patient by means of a thoracic drain tube and a suction system regulator, typically connected to the central vacuum system, provides the suction. It is usually employed to restore normal lung function following chest or mediastinal surgery (open heart surgery) or for medical conditions, e.g., pneumothorax and/or haemothorax. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
No Product Codes
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -5 and 30 Degrees Celsius
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal
Handling Environment Temperature: between -5 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 17.0 Centimeter
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Device Status

In Commercial Distribution
September 08, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05055270921451 10 05055270900067 In Commercial Distribution
05055270942852 8 05055270921451 In Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+4401914196988
gudid@rocketmedical.com
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