AccessGUDID - DEVICE: Benesta Fluid Pack (00857492008119)

GUDID

Device Identifier (DI) Information

Brand Name: Benesta Fluid Pack
Version or Model: CAL-1411
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Caldera Medical, Inc.

Primary DI Number: 00857492008119
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 130341956 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIH	Hysteroscope (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature, in a clean, dry location

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b19b09e0-674e-4987-a063-172ea51f5991
Public Version Date: July 26, 2022
Public Version Number: 1
DI Record Publish Date: July 18, 2022