Rocket

Basic Information

• Brand Name: Rocket
• Primary DI: 05055270913678
• Version / Model: R57405
• Catalog Number: R57405
• Company Name: ROCKET MEDICAL PLC
• Labeler DUNS: 544313588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 99c35078-32c0-404f-b747-b05f91db8793

Device Description

Rocket KCH Fetal Bladder Catheter

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
46234	Closed-wound drainage kit, micro-drainage	A collection of sterile devices designed to drain small, superficial abscesses and/or fluid collections. It will typically include an introducer needle, a guidewire, and a flexible, single-lumen, micro-drainage catheter with attached dilator that allows for atraumatic over-the-wire placement of the catheter. The initial puncture is made with the needle, the guidewire is advanced through the needle, which is then removed, and the catheter/dilator is advanced over the guidewire to obtain access to the site. The kit may have a wide range of surgical applications (e.g., general and plastic surgery). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05055270956460	GS1		30	In Commercial Distribution
Primary	05055270913678	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
H970001	000

Storage Conditions

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