Home GUDID 00857492008119 Benesta Fluid Pack
Primary DI 00857492008119
Brand Benesta Fluid Pack
Company Caldera Medical, Inc.
Model CAL-1411
Device description Benesta Fluid Pack for the Benesta Tissue Removal Device. Each pack contains: 1 single-use Y-Tubing and 2 single-use seals.
Published 2022-07-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name HIH Hysteroscope (And Accessories)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HIH Hysteroscope (And Accessories) Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00857492008089 Package GS1 5 In Commercial Distribution 00857492008119 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00857492008089 00857492008089 857492008089 0857492008089 00857492008119 00857492008119 857492008119 0857492008119
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store at room temperature, in a clean, dry location
Regulatory Flags# DUNS number 130341956 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Donation ID number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00857492008164 Benesta Hysteroscope Adapter CAL-TR1431 2022-07-19 00890594000124 Desara Blue TVez 3.0 CAL-DS01BTV30 2022-08-03 00890594000131 Desara TVez 2.7 CAL-DS01TV27 2022-08-03 00890594000155 Desara TVez 3.0 CAL-DS01TV30 2022-08-03 00890594000193 Desara Blue TVez 2.7 CAL-DS01BTV27 2022-08-03 00890594000087 Desara Blue TVez 3.0 CAL-DS01BTV30 2021-11-15 00890594000094 Desara Blue TVez 2.7 CAL-DS01BTV27 2021-11-15 00890594000100 Desara TVez 2.7 CAL-DS01TV27 2021-11-15 00890594000117 Desara TVez 3.0 CAL-DS01TV30 2021-11-15 00890594000230 Transvaginal 4.0 mm Introducer CAL-TV02 CAL-TV02 2019-09-30 00890594000865 Transvaginal 3.2 mm Introducer CAL-TV32 CAL-TV32 2019-09-30 00857492008041 Benesta Hysteroscope Set CAL-TR111 2022-08-03 00890594000933 Transobturator Inside-Out, Right 3.2 mm Introducer CAL-IOR32 CAL-IOR32 2019-11-05 00890594000940 Transobturator Inside-Out, Left 3.2 mm Introducer CAL-IOL32 CAL-IOL32 2019-11-05 00890594000018 Transobturator Helical, Left Introducer CAL-HL04 CAL-HL04 2019-09-30 00890594000148 Transobturator Helical, Right Introducer CAL-HR05 CAL-HR05 2019-09-30 00890594000162 Transobturator Large Helical, Left Introducer CAL-LHL1 CAL-LHL1 2019-09-30 00890594000179 Transobturator Large Helical, Right Introducer CAL-LHR2 CAL-LHR2 2019-09-30 00890594000186 Transobturator Inside-Out, Left Introducer CAL-IO6 CAL-IO6 2019-09-30 00890594000209 Transobturator Inside-Out, Right Introducer CAL-IO7 CAL-IO7 2019-09-30
Other Devices Sharing Product Codes# 
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