Rocket

Basic Information

• Brand Name: Rocket
• Primary DI: 05055270971609
• Version / Model: R51411-00-00
• Catalog Number: R51411-00-00
• Company Name: ROCKET MEDICAL PLC
• Labeler DUNS: 544313588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-18
• Public Version: 1
• Public Version Date: 2019-06-26
• Public Version Status: New
• Public Device Record Key: 6bef1475-7fe8-4198-bf4e-7632b69292e4

Device Description

Rocket IPC 1000ml Bottle

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWM	APPARATUS, SUCTION, PATIENT CARE	Cardiovascular	870.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11301	Closed-wound/centesis drainage receptacle	A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05055270971623	GS1	Box	5	In Commercial Distribution
Primary	05055270971609	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	1000.0	Milliliter

Storage Conditions

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