Rocket

Basic Information

• Brand Name: Rocket
• Primary DI: 05055270965240
• Version / Model: R58800-06-BK
• Catalog Number: R58800-06-BK
• Company Name: ROCKET MEDICAL PLC
• Labeler DUNS: 544313588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: f851e040-5f2e-484d-b093-59cdfb9cdb32

Device Description

Rocket BLUE Needle Drain Procedure Tray

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
32337	Abdominal paracentesis needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument used to perform therapeutic or diagnostic aspiration of fluids/air from the abdominal cavity. It may be used for the placement/operation of a paracentesis catheter or used directly without a catheter. It is typically made of high-grade stainless steel and may have an attached stopcock to control the aspiration process. The device is commonly used to remove ascites fluid from the peritoneal cavity. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05055270965257	GS1	Carton	5	In Commercial Distribution
Primary	05055270965240	GS1
Package	05055270965264	GS1	Box	2	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	6.0	French
Length	19.0	Centimeter

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 1 – 70 Percent (%) Relative Humidity
• 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