Benesta Fluid Pack

Basic Information

• Brand Name: Benesta Fluid Pack
• Primary DI: 00857492008119
• Version / Model: CAL-1411
• Company Name: Caldera Medical, Inc.
• Labeler DUNS: 130341956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-18
• Public Version: 1
• Public Version Date: 2022-07-26
• Public Version Status: New
• Public Device Record Key: b19b09e0-674e-4987-a063-172ea51f5991

Device Description

Benesta Fluid Pack for the Benesta Tissue Removal Device. Each pack contains: 1 single-use Y-Tubing and 2 single-use seals.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	884.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63212	Surgical suction system Y-piece valve-connector	A noninvasive tubular device intended to provide a connection between devices so that it is integrated within the tubing line of a suction assembly (e.g., of a tissue morcellation system with suction) where it can be used to introduce fluid into the suction line, typically to bathe a tissue sample captured within a filter. The device provides a channel for continuous suction and a side connector with an integrated valve to allow infusion of fluid without loss of suction; it may include a length of infusion line tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00857492008089	GS1	Box	5	In Commercial Distribution
Primary	00857492008119	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature, in a clean, dry location