100 ml Bulb and JP Flat 3/4 fenestration 3 x 7 mm

Basic Information

• Brand Name: 100 ml Bulb and JP Flat 3/4 fenestration 3 x 7 mm
• Primary DI: 08034139290584
• Version / Model: 10401
• Catalog Number: 10401
• Company Name: REDAX SPA
• Labeler DUNS: 338664915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-21
• Public Version: 3
• Public Version Date: 2021-05-05
• Public Version Status: Update
• Public Device Record Key: a5a711ba-f383-4936-8c44-2f6e42731fda

Device Description

The drainage system is composed of a silicone reservoir equipped with an anti-backflow valve and one or two connectors, and a drainage tube. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The silicone drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The subject product is compatible for use with gravity or suction drainage systems. The reservoir has a capacity of 100 ml. Thanks to the typical elasticity of silicone, the drainage suction power remains constant until the reservoir is completely full. The drainage system is a sterile and single-use device.

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	878.4680	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35824	Closed-wound drainage kit	A collection of devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors, a grasping device and possibly a trocar for placing the drains/catheters into the site. The reservoir will usually be provided with graduated markers along its side to facilitate the approximate measurement of the collected fluids. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18034139290581	GS1	Boc	10	In Commercial Distribution
Primary	08034139290584	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 60 Degrees Celsius