Prabadin

Basic Information

• Brand Name: Prabadin
• Primary DI: 00850051158003
• Version / Model: PRIT-1212
• Company Name: Prabadin Corp
• Labeler DUNS: 100803924
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-24
• Public Version: 1
• Public Version Date: 2023-04-03
• Public Version Status: New
• Public Device Record Key: 19837a75-9d84-49dc-b05b-6920ca88e0c6

Device Description

Prabadin Disposable, Single Use, Non Invasive, Vacuum-powered apparatus for the passthrough and suctioning of body fluids.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
GAZ	Tubing, Noninvasive	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46721	Disposable vacuum tubing	A sterile length of flexible tube intended to be used as a connection line between a vacuum source and a medical device, medical equipment, or a medical system that is dependent upon suction to operate or function. It is typically made of malleable synthetic polymer material(s) (e.g., plastic, silicone) and is designed with a thick wall to prevent collapse due to the negative pressure of the vacuum; it is available in a variety of lengths, including standard coil lengths. This device is used when sterile conditions are required (e.g., for an autologous blood transfusion system). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850051158000	GS1		25	In Commercial Distribution
Primary	00850051158003	GS1

Customer Contacts

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