AccessGUDID - DEVICE: Rocket (05055270900036)

GUDID

Device Identifier (DI) Information

Brand Name: Rocket
Version or Model: R54410-00-CP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R54410-00-CP
Company Name: ROCKET MEDICAL PLC

Primary DI Number: 05055270900036
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544313588 *Terms of Use

Device Description: Rocket IPC Replacement Valve Cap

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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
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.

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.

FDA Product Code

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Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123033	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d4687d7d-5cdf-46a7-976f-cbc1594bde2a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 08, 2016