Rocket

Basic Information

• Brand Name: Rocket
• Primary DI: 05055270920898
• Version / Model: R54410-16-11
• Catalog Number: R54410-16-11
• Company Name: ROCKET MEDICAL PLC
• Labeler DUNS: 544313588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6e32fc46-5317-476b-9f8e-5070f70dd449

Device Description

Rocket IPC Split Dilator 16G x 11cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
46215	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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05055270963680	GS1		8	In Commercial Distribution
Package	05055270942289	GS1		10	In Commercial Distribution
Primary	05055270920898	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123033	000

Device Sizes

Type	Value	Unit	Text
Length	11.0	Centimeter
Catheter Gauge	16.0	French

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 1 – 70 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -5 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 1 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -5 – 30 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 101 – 101 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 101 – 101 KiloPascal